PRODUCT CODE OSR
Pacemaker/Icd/Crt Non-Implanted Components
2026-06-03 – 2026-08-31 · FDA release 2026-09-29
Monitor reported device problems. This is a lead for evidence review. A report does not establish causation, fault, an eligible claimant or a future lawsuit. Multiple devices may appear in a report; device counts cannot be added into a unique-patient total.
Reports · 90 days
17,750Prior 90 days: 24,423Injury reports
10Source-classified event typeDeath reports
0Reported relationship is unverifiedReporting change
-27.3%Descriptive change, not a risk estimateMalfunction-classified reports in this window: 17,736. These are separate from injury/death classifications.
Recent source reports
Up to five example reports. Statistics above cover all matching API-index entries in the stated windows; these examples are not a representative sample.
CareLink SmartSync Common App iOS
Read FDA report 50515694 ↗Received 2026-08-31 · Malfunction
Patient problems: No Clinical Signs, Symptoms or Conditions
Device problems: Communication or Transmission Problem
CareLink SmartSync Common App iOS
Read FDA report 50515697 ↗Received 2026-08-31 · Malfunction
Patient problems: No Clinical Signs, Symptoms or Conditions
Device problems: Communication or Transmission Problem
CareLink SmartSync Common App iOS
Read FDA report 50515705 ↗Received 2026-08-31 · Malfunction
Patient problems: No Clinical Signs, Symptoms or Conditions
Device problems: Communication or Transmission Problem
CareLink SmartSync Common App iOS
Read FDA report 50515713 ↗Received 2026-08-31 · Malfunction
Patient problems: No Clinical Signs, Symptoms or Conditions
Device problems: Communication or Transmission Problem
CareLink SmartSync Common App iOS
Read FDA report 50515736 ↗Received 2026-08-31 · Malfunction
Patient problems: No Clinical Signs, Symptoms or Conditions
Device problems: Communication or Transmission Problem
Investigate before assessing a potential case
Review the complete report, model and device identifiers, recalls, medical literature, alternative causes and current court records. Check follow-ups and duplicate submissions. Report volume alone cannot establish incidence, liability or case value.