Pamira S DX 65/17 428776Recalls & 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 is a permanent defibrillator lead. Reports mostly mention leads dislodging or systems being explanted because of infection. There are 41 reports, no deaths, and 27 injuries. 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
- 42
- Deaths reported
- 0
- Injuries reported
- 28
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 42 adverse event reports that list this exact device (DI 04035479156527), received between Jul 27, 2023 and Sep 29, 2026 — classified as 28 injuries, 14 malfunctions.
The most frequently reported specific device problem is “Device Dislodged or Dislocated” (14 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 Problem17
- Device Dislodged or Dislocated14
- Ambient Noise Problem4
- Fracture3
- High Capture Threshold3
- Device Sensing Problem2
- Impedance Problem1
- Over-Sensing1
Patient problems
- No Clinical Signs, Symptoms or Conditions25
- Unspecified Infection14
- Pocket Erosion2
- Wound Dehiscence2
- Bacteremia1
- Cardiac Perforation1
- Hematoma1
Recent adverse event reports
The 25 most recent of 42 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 50926794 ↗InjurySep 2, 2026Device Dislodged or Dislocated
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50576285 ↗InjuryAug 31, 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 50527629 ↗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 50178719 ↗MalfunctionAug 4, 2026Ambient Noise Problem; Device Sensing Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50124615 ↗InjuryMay 26, 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 25290422 ↗InjuryMay 21, 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 25249767 ↗InjuryApr 17, 2026Adverse Event Without Identified Device or Use Problem
SYSTEM WAS EXPLANTED DUE TO INFECTION WITH POCKET AVULSION. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THIS FILE WILL BE UPDATED.
Patient problems: Pocket Erosion; Unspecified Infection
MAUDE report 24911488 ↗InjuryApr 16, 2026Device Dislodged or Dislocated
ON CT ANGIOGRAM, LEAD WAS FOUND TO BE IN THE ARTERIAL SYSTEM. FOUND TO BE IN AORTA AND PLACED IN THE LEFT VENTRICLE. LEAD WAS REPOSITIONED AND REMAINS IMPLANTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24905898 ↗InjuryApr 9, 2026Device Dislodged or Dislocated
LEAD WAS EXPLANTED DUE DISLODGEMENT. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THIS FILE WILL BE UPDATED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24835785 ↗InjuryMar 30, 2026Device Sensing Problem; High Capture Threshold
THIS LEAD WAS EXPLANTED DUE TO ELEVATED RV THRESHOLD AND NO ATRIAL SIGNAL. 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 24735865 ↗InjuryMar 12, 2026Under-Sensing
THE ATRIAL SENSING DIPOLE OF THIS LEAD WAS UNDER-SENSING ATRIAL ACTIVITY. A SOLIA S 53 PACING LEAD WAS IMPLANTED IN THE RIGHT ATRIUM. THE IS-1 PIN OF THIS DX LEAD IS CAPPED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24585266 ↗InjuryMar 12, 2026Device Dislodged or Dislocated
THIS LEAD WAS EXPLANTED DUE TO DISLODGEMENT CAUSED BY PATIENT FLAILING. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THIS FILE WILL BE UPDATED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24583993 ↗InjuryMar 2, 2026Device Dislodged or Dislocated
THIS LEAD WAS EXPLANTED DUE TO DISLODGEMENT. PATIENT WAS VIOLENT WHEN HE WOKE UP YESTERDAY AFTER THE PROCEDURE AND DISLODGED HIS LEAD. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THIS FILE WILL BE UPDATED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24482948 ↗MalfunctionFeb 13, 2026Ambient Noise Problem
POST IMPLANT, THERE IS A RECORDING SHOWING A COUPLE EVENTS OF WHAT APPEAR TO BE NOISE ON FARFIELD AND RV CHANNEL. ADVISED FULL EVALUATION TO SEE IF NOISE COULD BE REPLICATED. CURRENTLY ALL VALUES ARE SAME AS AT IMPLANT OF LEAD. LEAD REMAINS IMPLANTED. SHOULD ADDITIONAL INFORMATION BE RECEIVED THIS FILE WILL BE UPDATED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24334562 ↗InjuryFeb 10, 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 24309634 ↗InjuryFeb 2, 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 24241977 ↗MalfunctionJan 29, 2026Ambient Noise Problem
THIS LEAD SHOWS NOISE. 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 24209076 ↗InjuryJan 19, 2026Adverse Event Without Identified Device or Use Problem
SYSTEM WAS EXPLANTED DUE TO INFECTION WITH WOUND DEHISCENCE. PHYSICIAN NOTED PT POSSIBLY MANIPULATED DEVICE AT HOME. PATIENT WAS PREVIOUSLY INTUBATED IN THE ED. PATIENT LEFT EP LAB IN STABLE CONDITION AND WENT TO ICU. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THIS FILE WILL BE UPDATED.
Patient problems: Unspecified Infection; Wound Dehiscence
MAUDE report 24109440 ↗InjuryDec 15, 2025Adverse Event Without Identified Device or Use Problem; Adverse 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 23802606 ↗InjuryNov 20, 2025Adverse Event Without Identified Device or Use Problem; Adverse 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 23612097 ↗InjuryNov 18, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
THIS LEAD WAS EXPLANTED DUE TO POSSIBLE RV LEAD PERFORATION. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THIS FILE WILL BE UPDATED.
Patient problems: Cardiac Perforation
MAUDE report 23582237 ↗InjuryNov 17, 2025Adverse Event Without Identified Device or Use Problem; Adverse 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 23568862 ↗MalfunctionOct 24, 2025Impedance Problem; High Capture Threshold; Impedance Problem; High Capture Threshold
HMSC REPORTED SHOCK IMPEDANCE GRADUALLY INCREASING SINCE IMPLANT. LAST MEASURED VALUE REPORTED WAS 129 OHMS ON (B)(6) 2025. (B)(6) ALSO REPORTED THAT THE LEAD THRESHOLDS WERE CHRONICALLY ELEVATED SINCE IMPLANT. ALL OTHER VALUES REMAINED WITHIN RANGE. NO NOISE EVIDENT ON RECORDINGS. ADVISED FURTHER EVALUATION OF LEAD. LEAD REMAINS IMPLANTED. SHOULD ADDITIONAL INFORMATION BE RECEIVED THIS FILE WILL BE UPDATED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23383136 ↗MalfunctionOct 20, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated
THIS LEAD WAS REPOSITIONED DUE TO DISLODGEMENT AND REMAINS IMPLANTED. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THIS FILE WILL BE UPDATED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23343554 ↗
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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