Pamira S 65 428769Recalls & reported problems
BIOTRONIK SE & Co. KG · Class 3 · Implant
Data updated Oct 18, 2026 from official FDA records · Editorial policy
Quick summary
This BIOTRONIK permanent defibrillator electrode (lead) is implanted in the heart to deliver shock therapy. Reports mostly describe leads that shift out of position and have to be removed, sometimes after puncturing the heart wall, along with infection and blood build-up that led to explanting the system. There are 59 adverse event reports, with 41 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
- 60
- Deaths reported
- 0
- Injuries reported
- 43
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 60 adverse event reports that list this exact device (DI 04035479156459), received between May 22, 2024 and Sep 25, 2026 — classified as 43 injuries, 17 malfunctions.
The most frequently reported specific device problem is “Device Dislodged or Dislocated” (20 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 Problem31
- Device Dislodged or Dislocated20
- High Capture Threshold4
- Ambient Noise Problem3
- Failure to Capture3
- High impedance3
- Impedance Problem2
- Device Sensing Problem1
Patient problems
- Unspecified Infection26
- No Clinical Signs, Symptoms or Conditions23
- Cardiac Perforation4
- Hematoma2
- Bacteremia1
- Loss of consciousness1
- Obstruction/Occlusion1
- Pocket Erosion1
Recent adverse event reports
The 25 most recent of 60 reports, in the reporter's own words as published by the FDA.
InjurySep 25, 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 50899790 ↗InjurySep 25, 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 50899521 ↗InjuryAug 31, 2026Failure to Capture; Device Dislodged or Dislocated; High Capture Threshold
This RV lead was explanted due to dislodgement resulting in loss of capture and high DFT. Should additional information be received, this file will be updated.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50530984 ↗MalfunctionAug 18, 2026High impedance
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50311428 ↗InjuryAug 13, 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 50235538 ↗InjuryAug 12, 2026Device Dislodged or Dislocated
This lead was explanted due to dislodgement resulting in perforated RV. Should additional information be received, this file will be updated.
Patient problems: Cardiac Perforation
MAUDE report 50230119 ↗InjuryJul 6, 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 25719606 ↗InjuryJun 17, 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 25539622 ↗InjuryJun 9, 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 25444433 ↗InjuryMay 15, 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 25185240 ↗InjuryMay 15, 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 25185169 ↗MalfunctionMay 15, 2026High impedance; Ambient Noise Problem
OUT OF RANGE SHOCK IMPEDANCE (GREATER THAN 150 OHMS) AND WHAT APPEARS TO BE INTERMITTENT NOISE ON THE RV CHANNEL WERE REPORTED. LEAD TO BE EVALUATED FURTHER AND REMAINS IMPLANTED. NO ADVERSE PATIENT EVENTS WERE REPORTED. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THIS FILE WILL BE UPDATED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25183803 ↗InjuryMay 7, 2026Adverse Event Without Identified Device or Use Problem
THIS LEAD WAS EXPLANTED DUE TO SVC SYNDROME. SHOULD ADDITIONAL INFORMATION BE RECEIVED THIS FILE WILL BE UPDATED.
Patient problems: Obstruction/Occlusion
MAUDE report 25111567 ↗InjuryMay 6, 2026Adverse Event Without Identified Device or Use Problem
SYSTEM WAS EXPLANTED DUE TO VEGETATION ON LEAD. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THIS FILE WILL BE UPDATED.
Patient problems: Unspecified Infection
MAUDE report 25094255 ↗InjuryMay 5, 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 25088560 ↗InjuryApr 13, 2026Adverse Event Without Identified Device or Use Problem
THIS SYSTEM WAS EXPLANTED DUE TO POCKET EROSION/INFECTION. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THIS FILE WILL BE UPDATED.
Patient problems: Pocket Erosion; Unspecified Infection
MAUDE report 24859132 ↗InjuryMar 23, 2026Device Dislodged or Dislocated
LEAD WAS REPOSITIONED DUE TO DISLODGEMENT. LEAD REMAINS IMPLANTED. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THIS FILE WILL BE UPDATED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24664792 ↗InjuryMar 12, 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 24584746 ↗InjuryFeb 11, 2026Malposition of Device
THIS LEAD WAS EXPLANTED DUE TO, AT ORIGINAL IMPLANT, THIS RV LEAD WAS IMPLANTED INTO THE LV THROUGH AN ASD. ALL LEAD FUNCTIONS WERE NORMAL. IT WAS DISCOVERED ON AN ECHOCARDIOGRAM OF THE HEART. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THIS FILE WILL BE UPDATED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24314922 ↗InjuryFeb 10, 2026Device Sensing Problem; Device Dislodged or Dislocated
THIS RV LEAD WAS EXPLANTED DUE TO POTENTIAL MICRO-DISLODGEMENT AS EVIDENCED BY SENSING DROP TO 2MV. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THIS FILE WILL BE UPDATED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24309599 ↗InjuryJan 26, 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: Bacteremia
MAUDE report 24185309 ↗InjuryJan 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 24111518 ↗MalfunctionJan 5, 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 23956674 ↗MalfunctionDec 29, 2025Failure to Capture; Failure to Capture
THIS LEAD WAS EXPLANTED DUE TO NO CAPTURE AND PATIENT NEEDED POCKET EVACUATION DUE TO HEMATOMA. SHOULD ADDITIONAL INFORMATION BE RECEIVED THIS FILE WILL BE UPDATED.
Patient problems: Hematoma
MAUDE report 23910892 ↗InjuryDec 17, 2025Inappropriate/Inadequate Shock/Stimulation; Ambient Noise Problem; Impedance Problem; Inappropriate/Inadequate Shock/Stimulation; Ambient Noise Problem; Impedance Problem
DURING CLINIC CHECK, IT WAS NOTED PATIENT HAD INAPPROPRIATE SHOCKS, NOISE AND LEAD IMPEDANCE WAS LESS THAN 200. DETECTION WAS TURNED OFF AND PHYSICIAN WILL REPLACE SYSTEM AT A FUTURE DATE. SYSTEM REMAINS IMPLANTED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THIS FILE WILL BE UPDATED.
Patient problems: Shock from Patient Lead(s)
MAUDE report 23829666 ↗
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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