Pamira S DX 65/15 428775Recalls & 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 defibrillator lead has 203 adverse event reports, with 108 injuries and no deaths. Many describe the lead shifting out of position, including cases where it twisted, and infections that led to removing the system. One report describes a lead that punctured a major vein during placement. 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
- 212
- Deaths reported
- 0
- Injuries reported
- 115
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 212 adverse event reports that list this exact device (DI 04035479156510), received between Mar 7, 2024 and Sep 29, 2026 — classified as 115 injuries, 97 malfunctions.
The most frequently reported specific device problem is “Device Dislodged or Dislocated” (88 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 Dislocated88
- Adverse Event Without Identified Device or Use Problem81
- Ambient Noise Problem23
- Device Sensing Problem23
- High Capture Threshold10
- Impedance Problem7
- Failure to Capture6
- High impedance5
Patient problems
- No Clinical Signs, Symptoms or Conditions106
- Unspecified Infection70
- Twiddlers Syndrome19
- Shock from Patient Lead(s)5
- Cardiac Perforation4
- Ventricular Fibrillation2
- Wound Dehiscence2
- Bacteremia1
Recent adverse event reports
The 25 most recent of 212 reports, in the reporter's own words as published by the FDA.
InjurySep 29, 2026Adverse Event Without Identified Device or Use Problem
Patient problems: Unspecified Infection
MAUDE report 50926784 ↗InjurySep 29, 2026Adverse Event Without Identified Device or Use Problem
Patient problems: Unspecified Infection
MAUDE report 50926762 ↗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 50899788 ↗InjurySep 24, 2026Device Sensing Problem
This lead was explanted due to low R waves (2mV). 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 50886523 ↗InjurySep 16, 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 50788582 ↗InjurySep 16, 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 50788230 ↗MalfunctionSep 16, 2026Ambient Noise Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50788087 ↗InjurySep 15, 2026Device Sensing Problem
Lead was explanted and replaced due to low R waves following implant. No adverse patient events were reported.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50778905 ↗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 50734230 ↗MalfunctionSep 2, 2026Ambient Noise Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50576304 ↗InjurySep 2, 2026Device Sensing Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50569221 ↗InjurySep 2, 2026Adverse Event Without Identified Device or Use Problem
Patient problems: Unspecified Infection
MAUDE report 50569119 ↗InjurySep 1, 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 50554021 ↗InjuryAug 31, 2026Device Dislodged or Dislocated
This lead was explanted due to dislodgement as a possible result of twiddler syndrome. Should additional information be received, this file will be updated.
Patient problems: Twiddlers Syndrome
MAUDE report 50526525 ↗InjuryAug 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 50278969 ↗InjuryAug 10, 2026Adverse Event Without Identified Device or Use Problem
System was explanted due to infection. Should additional information become available, this file will be updated.
Patient problems: Unspecified Infection
MAUDE report 50191825 ↗InjuryAug 6, 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 50163965 ↗MalfunctionJul 30, 2026Over-Sensing; Device Sensing Problem; High Capture Threshold
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50084090 ↗InjuryJul 8, 2026Adverse Event Without Identified Device or Use Problem
SYSTEM AND PREVIOUSLY CAPPED LEAD WERE EXPLANTED DUE TO INFECTION. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THIS FILE WILL BE UPDATED.
Patient problems: Unspecified Infection
MAUDE report 25757127 ↗MalfunctionJun 25, 2026Ambient Noise Problem
RIGHT VENTRICULAR (RV) LEAD NOISE SEEN ON STORED RECORDINGS. DAILY SHORT RV INTERVAL COUNTS HAVE BEEN DETECTED SINCE IMPLANTATION. LEAD 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 25630549 ↗InjuryJun 22, 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 25588216 ↗InjuryJun 22, 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 25588212 ↗InjuryJun 18, 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 25548735 ↗InjuryJun 8, 2026Adverse Event Without Identified Device or Use Problem
SYSTEM WAS EXPLANTED DUE TO INFECTION WITH WOUND DEHISCENCE. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THIS FILE WILL BE UPDATED.
Patient problems: Unspecified Infection; Wound Dehiscence
MAUDE report 25427680 ↗MalfunctionJun 1, 2026Ambient Noise Problem
EVIDENT NOISE ON RA AND FAR FIELD CHANNELS, FULL LEAD EVALUATION RECOMMENDED. LEAD CURRENTLY REMAINS IMPLANTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25348811 ↗
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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