Pamira SD 60/16 428771Recalls & reported problems
BIOTRONIK SE & Co. KG · Class 3 · Implant
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 5
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 04035479156473), received between Jan 28, 2025 and Feb 20, 2026 — classified as 2 injuries, 3 malfunctions.
The most frequently reported specific device problem is “Device Dislodged or Dislocated” (2 reports).
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.
Reports received per month
Most reported problems
Device problems
- Device Dislodged or Dislocated2
- Adverse Event Without Identified Device or Use Problem1
- Ambient Noise Problem1
- Impedance Problem1
- Low impedance1
- Unstable Capture Threshold1
Patient problems
- No Clinical Signs, Symptoms or Conditions4
- Unspecified Infection1
Recent adverse event reports
The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.
InjuryFeb 20, 2026Device Dislodged or Dislocated
THIS LEAD WAS EXPLANTED DUE TO DISLODGEMENT. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THIS FILE WILL BE UPDATED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24400160 ↗MalfunctionOct 28, 2025Low impedance; Low impedance
THIS LEAD SHOWS LOW SHOCK AND PACING IMPEDANCES. LEAD REMAINS IMPLANTED. NO ADVERSE PATIENT EVENTS WERE REPORTED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THIS FILE WILL BE UPDATED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23405006 ↗MalfunctionAug 4, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated
THIS LEAD WAS EXPLANTED DUE TO DISLODGEMENT. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THIS FILE WILL BE UPDATED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22709974 ↗InjuryApr 28, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
SYSTEM EXPLANTED DUE TO INFECTION. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THIS FILE WILL BE UPDATED.
Patient problems: Unspecified Infection
MAUDE report 21919025 ↗MalfunctionJan 28, 2025Ambient Noise Problem; Impedance Problem; Unstable Capture Threshold; Ambient Noise Problem; Impedance Problem; Unstable Capture Threshold
THIS LEAD WAS EXPLANTED DUE TO NOISE. THE THRESHOLDS HAVE ALSO BEEN TRENDING UP AND THE IMPEDANCES HAVE BEEN TRENDING DOWN. NO ADVERSE PATIENT EVENTS WERE REPORTED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THIS FILE WILL BE UPDATED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21255422 ↗
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Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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