Device: Pacemakers And Defibrillators

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14 adverse event reports submitted to the FDA

Important: Adverse event reports do not establish that a drug caused or contributed to the event. Consult your veterinarian before making treatment decisions.
14
Total Reports
2
Deaths Reported
1430.0%
Death Rate

Active Ingredients

Device: Pacemakers And Defibrillators

Administration Routes

UnknownSubcutaneous

Species Affected

Unknown 7
Dog 5
Pig 1
Other 1

Most Affected Breeds

Unknown 9
Dog (unknown) 2
Pig (unknown) 1
Affenpinscher 1
Retriever - Labrador 1

Most Reported Reactions

Product Defect, General 6
Device Defective NOS 4
Death 2
Syncope 2
Device failure 2
Collapse NOS (see also 'Cardio-vascular' and 'Neurological disorders') 2
Medical device replacement 2
Lack of efficacy, medical device 1
Device Complication NOS 1
Broken components, medical device 1
Haemorrhagic diarrhoea 1
Circulatory shock 1

Outcome Breakdown

Died
2 (40.0%)
Recovered/Normal
2 (40.0%)
Outcome Unknown
1 (20.0%)

Data Summary

Metric Value
Total adverse event reports 14
Reports involving death 2
Case-fatality rate (reported events) 1430.0%
Distinct species in reports 4
Distinct breeds in reports 5
Distinct reactions reported 15
Active ingredients on file 1

Source: FDA Center for Veterinary Medicine — Adverse Event Reporting (CVM AER). Counts reflect voluntary reports only.

Device: Pacemakers And Defibrillators Adverse Event Insights

The FDA Center for Veterinary Medicine database currently holds 14 adverse event reports referencing Device: Pacemakers And Defibrillators, including 2 reports in which the animal died — a 1430.0% case-fatality figure among reported events only, not a population-level mortality rate. Active ingredient on file: Device: Pacemakers And Defibrillators. Reported administration routes include Unknown, Subcutaneous. These numbers reflect voluntary submissions from pet owners, veterinarians, and manufacturers and therefore under-represent mild events and over-represent severe ones — a pattern the FDA has documented repeatedly for pharmacovigilance datasets.

The species most frequently named in Device: Pacemakers And Defibrillators reports are Unknown (7 reports), Dog (5 reports), Pig (1 reports), with Unknown accounting for the largest share. Within those species, Unknown (9), Dog (unknown) (2), Pig (unknown) (1) appear most often — though breed popularity and ownership density shape these counts as much as any drug-specific sensitivity. This distribution matters because the same active ingredient can behave very differently across body sizes, ages, and species physiology.

The most commonly reported clinical signs associated with Device: Pacemakers And Defibrillators are Product Defect, General (6), Device Defective NOS (4), Death (2), Syncope (2). Of the 5 reports with a coded outcome, Died is the leading category at 40.0%. Because FDA adverse event data describes correlation rather than causation, these figures are best used to frame informed questions with a veterinarian and to compare reporting patterns across related products — not as a standalone safety verdict on Device: Pacemakers And Defibrillators.

Source: FDA Center for Veterinary Medicine — Adverse Event Reports FDA Center for Veterinary Medicine — Adverse Event Reports Data reflects voluntary submissions and may not represent actual incidence rates

Related

Data sourced from official AKC, AVMA, ACVO, and breed-club veterinary references. See our methodology for details. Retrieved and formatted by PlainBreed Editorial