Pamira S 60 428768Recalls & reported problems
BIOTRONIK SE & Co. KG · Class 3 · Implant
Data updated Oct 18, 2026 from official FDA records · Editorial policy
Quick summary
This Biotronik Pamira S 60 defibrillator electrode sits under the skin to deliver pacing and shock therapy. Most of the 62 reports describe leads that shift out of position in the chest, often because patients twiddle the wire in the implant pocket, along with infections and some perforation of the heart wall. Reports describe 44 injuries and no deaths. No recalls name this device.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 65
- Deaths reported
- 0
- Injuries reported
- 47
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 65 adverse event reports that list this exact device (DI 04035479156442), received between Apr 16, 2024 and Sep 28, 2026 — classified as 47 injuries, 18 malfunctions.
The most frequently reported specific device problem is “Device Dislodged or Dislocated” (26 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
- Adverse Event Without Identified Device or Use Problem30
- Device Dislodged or Dislocated26
- Device Sensing Problem5
- Failure to Capture3
- Ambient Noise Problem2
- High Capture Threshold2
- Failure to Convert Rhythm1
- Fracture1
Patient problems
- No Clinical Signs, Symptoms or Conditions26
- Unspecified Infection23
- Cardiac Perforation5
- Twiddlers Syndrome5
- Fall2
- Pocket Erosion2
- Atrial Fibrillation1
- Undesired Nerve Stimulation1
Recent adverse event reports
The 25 most recent of 65 reports, in the reporter's own words as published by the FDA.
InjurySep 28, 2026Adverse Event Without Identified Device or Use Problem
System was explanted due to infection. Should additional information be received, this file will be updated.
Patient problems: Unspecified Infection
MAUDE report 50915668 ↗InjurySep 11, 2026Adverse Event Without Identified Device or Use Problem
System was explanted due to infection. Should additional information be received, this file will be updated.
Patient problems: Unspecified Infection
MAUDE report 50734846 ↗InjurySep 11, 2026Adverse Event Without Identified Device or Use Problem
System was explanted due to infection. Should additional information be received, this file will be updated.
Patient problems: Unspecified Infection
MAUDE report 50734229 ↗InjurySep 4, 2026Adverse Event Without Identified Device or Use Problem
System was explanted due to infection. Should additional information be received, this file will be updated.
Patient problems: Unspecified Infection
MAUDE report 50615323 ↗InjuryAug 19, 2026Adverse Event Without Identified Device or Use Problem
This system was explanted due to infection. Should additional information become available, this file will be updated.
Patient problems: Unspecified Infection
MAUDE report 50333026 ↗InjuryAug 12, 2026Device Dislodged or Dislocated
This lead was explanted due to dislodgement as a result of twiddling. Should additional information be received, this file will be updated.
Patient problems: Twiddlers Syndrome
MAUDE report 50217200 ↗InjuryAug 11, 2026Device Dislodged or Dislocated
This lead was repositioned due to dislodgement caused by patient twiddling. Should additional information be received, this file will be updated.
Patient problems: Twiddlers Syndrome
MAUDE report 50201875 ↗InjuryAug 10, 2026Device Dislodged or Dislocated
This lead was explanted due to dislodgement as a result of twiddling. Should additional information be received, this file will be updated.
Patient problems: Twiddlers Syndrome
MAUDE report 50198770 ↗InjuryAug 7, 2026Failure to Capture; Device Dislodged or Dislocated; Impedance Problem
This lead was explanted due to dislodgement resulting in no capture at max outputs and lead impedance drop. Should additional information be received, this file will be updated.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50180554 ↗InjuryAug 7, 2026Adverse Event Without Identified Device or Use Problem
System was explanted due to infection. Should additional information be received, this file will be updated.
Patient problems: Unspecified Infection
MAUDE report 50179414 ↗InjuryJun 1, 2026Adverse Event Without Identified Device or Use Problem
SYSTEM WAS EXPLANTED DUE TO INFECTION. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THIS FILE WILL BE UPDATED.
Patient problems: Unspecified Infection
MAUDE report 25348852 ↗InjuryMay 11, 2026Failure to Capture
LEAD WAS REPOSITIONED DUE TO LOSS OF CAPTURE AT 7.5. LEAD REMAINS IMPLANTED. SHOULD ADDITIONAL INFORMATION BE RECEIVED THIS FILE WILL BE UPDATED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25135349 ↗InjuryApr 27, 2026Adverse Event Without Identified Device or Use Problem
SYSTEM WAS EXPLANTED DUE TO INFECTION. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THIS FILE WILL BE UPDATED.
Patient problems: Unspecified Infection
MAUDE report 25009100 ↗InjuryApr 27, 2026Adverse Event Without Identified Device or Use Problem
SYSTEM WAS EXPLANTED DUE TO INFECTION. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THIS FILE WILL BE UPDATED.
Patient problems: Unspecified Infection
MAUDE report 25000677 ↗InjuryApr 23, 2026Device Dislodged or Dislocated
THIS RV LEAD WAS REPOSITIONED DUE TO DISLODGEMENT. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THIS FILE WILL BE UPDATED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24973577 ↗InjuryApr 6, 2026Device 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 24790258 ↗InjuryMar 20, 2026Device Sensing Problem; Device Dislodged or Dislocated
RV LEAD WAS EXPLANTED BECAUSE IT DISLODGED CAUSING R WAVES DROPPED FROM 22 TO 2.0 MV. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THIS FILE WILL BE UPDATED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24651943 ↗InjuryMar 13, 2026Device Dislodged or Dislocated
THIS LEAD WAS EXPLANTED DUE TO DISLODGEMENT AFTER PATIENT FELL. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THIS FILE WILL BE UPDATED.
Patient problems: Fall
MAUDE report 24599045 ↗InjuryMar 13, 2026Device Dislodged or Dislocated
THIS LEAD WAS EXPLANTED DUE TO DISLODGEMENT AFTER A FALL. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THIS FILE WILL BE UPDATED.
Patient problems: Fall
MAUDE report 24591867 ↗InjuryMar 11, 2026Adverse Event Without Identified Device or Use Problem
SYSTEM WAS EXPLANTED DUE TO INFECTION. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THIS FILE WILL BE UPDATED.
Patient problems: Unspecified Infection
MAUDE report 24573541 ↗InjuryMar 11, 2026Ambient Noise Problem
NOISE SEEN ON RV CHANNEL. RECOMMENDED DISCUSSING WITH PHYSICIAN. DEVICE REMAINS IMPLANTED. SHOULD ADDITIONAL INFORMATION BE RECEIVED THIS FILE WILL BE UPDATED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24572086 ↗InjuryMar 2, 2026Device Dislodged or Dislocated
THIS LEAD WAS REPOSITIONED DUE TO DISLODGEMENT (PULLED BACK FROM ORIGINAL POSITION). SHOULD ADDITIONAL INFORMATION BE RECEIVED, THIS FILE WILL BE UPDATED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24482998 ↗InjuryFeb 23, 2026Inappropriate/Inadequate Shock/Stimulation
THIS LEAD WAS EXPLANTED DUE TO UNDESIRED CHEST WALL STIM. SHOULD ADDITIONAL INFORMATION BE RECEIVED THIS FILE WILL BE UPDATED.
Patient problems: Undesired Nerve Stimulation
MAUDE report 24421662 ↗InjuryFeb 18, 2026Device Dislodged or Dislocated
SYSTEM WAS EXPLANTED DUE TO DISLODGEMENT CAUSE BY PATIENT TWIDDLING. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THIS FILE WILL BE UPDATED.
Patient problems: Twiddlers Syndrome
MAUDE report 24384667 ↗InjuryFeb 10, 2026Adverse Event Without Identified Device or Use Problem
SYSTEM EXPLANTED DUE TO POCKET EROSION. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THIS FILE WILL BE UPDATED.
Patient problems: Pocket Erosion
MAUDE report 24303496 ↗
Other Permanent defibrillator electrodes devices
- CapSureFix Novus MRI™ SureScan® 5076-52Medtronic, Inc. · Permanent defibrillator electrodes333 deaths30,581 reports
- Sprint Quattro Secure S MRI™ SureScan™ 6935M62Medtronic, Inc. · Permanent defibrillator electrodes221 deaths14,405 reports
- Capsurefix® Novus 5076-52Medtronic, Inc. · Permanent defibrillator electrodes111 deaths9,860 reports
- CapSureFix Novus MRI™ SureScan® 5076-52Medtronic, Inc. · Permanent defibrillator electrodes80 deaths8,280 reports
- Sprint Quattro Secure S MRI™ SureScan™ 6935M55Medtronic, Inc. · Permanent defibrillator electrodes116 deaths7,750 reports
- Durata™ 7122Q-58St. Jude Medical, Inc. · Permanent defibrillator electrodes151 deaths6,202 reports
- Durata™ 7122Q-65St. Jude Medical, Inc. · Permanent defibrillator electrodes86 deaths4,773 reports
- Capsurefix® Novus 5076-58Medtronic, Inc. · Permanent defibrillator electrodes47 deaths4,587 reports
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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