Safio S 60 370946Recalls & reported problems

Summary

The FDA's MAUDE database contains 35 adverse event reports that list this exact device (DI 04035479113957), received between Apr 9, 2019 and Aug 7, 2022 — classified as 2 injuries, 33 malfunctions.

The most frequently reported specific device problem is “Over-Sensing” (12 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.

Most reported problems

Recent adverse event reports

The 25 most recent of 35 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 7, 2022Over-Sensing; Over-Sensing

  AFTER AN IMPLANTATION PERIOD OF APPROX. 62 MONTHS, OVERSENSING ON THE VENTRICULAR CHANNEL WAS REPORTED. 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 15180784 ↗
• MalfunctionApr 1, 2022Over-Sensing; Over-Sensing

  AFTER AN IMPLANTATION PERIOD OF APPROX. 43 MONTHS, OVERSENSING ON THE VENTRICULAR CHANNEL WAS REPORTED. THE LEAD WAS EXPLANTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13972357 ↗
• MalfunctionMar 2, 2022High Capture Threshold; High Capture Threshold

  AFTER AN IMPLANTATION PERIOD OF APPROX. 32 MONTHS, AN INCREASING THRESHOLD WAS OBSERVED AT THE FOLLOW-UP. DURING REVISION PHYSICIAN HAD DIFFICULTIES REMOVING THE VENTRICULAR LEAD FROM THE HEADER. THE PACEMAKER WAS EXPLANTED AND THE LEAD WAS CAPPED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13657064 ↗
• MalfunctionOct 14, 2021Over-Sensing; Low impedance; Over-Sensing; Low impedance

  AFTER AN IMPLANTATION PERIOD OF APPROXIMATELY 55 MONTHS, IT WAS REPORTED THAT OVERSENSING AND DECREASED IMPEDANCE WERE DETECTED. A LEAD REPLACEMENT IS TO BE SCHEDULED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12636456 ↗
• MalfunctionAug 19, 2021Over-Sensing; Over-Sensing

  AFTER AN IMPLANTATION PERIOD OF APPROXIMATELY 128 MONTHS, IT WAS REPORTED THAT THE LEAD WAS EXTRACTED DUE TO OVERSENSING IN THE VENTRICULAR CHANNEL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12344290 ↗
• MalfunctionJul 7, 2021High impedance; High Capture Threshold; High impedance; High Capture Threshold

  IT WAS REPORTED THAT THE LEAD WAS EXPLANTED APPROX. 65 MONTHS AFTER THE IMPLANTATION DUE TO INCREASING IMPEDANCE AND PACING THRESHOLD RESULTING IN AN EXIT BLOCK.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12129436 ↗
• InjuryJun 10, 2021High Capture Threshold; High Capture Threshold

  IT WAS REPORTED THAT THE LEAD WAS EXTRACTED DUE TO INCREASED THRESHOLD AND EXIT BLOCK DETECTION APPROX. 24 MONTHS AFTER THE IMPLANTATION. PATIENT EXPERIENCED DIZZINESS AND LOSS OF CONSCIOUSNESS.

  Patient problems: Dizziness; Syncope/Fainting

  MAUDE report 11980198 ↗
• MalfunctionMar 17, 2021Over-Sensing; Over-Sensing

  AFTER AN IMPLANTATION PERIOD OF APPROX. 82 MONTHS, OVERSENSING ON THE VENTRICULAR CHANNEL WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11504653 ↗
• MalfunctionFeb 18, 2021Over-Sensing; Over-Sensing

  AFTER AN IMPLANTATION PERIOD OF APPROX. 41 MONTHS, OVERSENSING ON THE VENTRICULAR CHANNEL WAS REPORTED. THE LEAD WAS CAPPED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11342410 ↗
• MalfunctionJan 26, 2021Break; Over-Sensing; Ambient Noise Problem; Break; Over-Sensing; Ambient Noise Problem

  ON (B)(6) 2021, IT WAS REPORTED TO (B)(6) HOSPITAL FROM (B)(6) HOSPITAL THAT THERE WAS A NOISE IN THE RV LEAD. ON (B)(6) 2021, EXPLANTATION WAS PERFORMED. DURING INTERROGATION, VENTRICULAR SENSING WAS SET TO UNIPOLAR AND SENSITIVITY WAS SET TO 7.5 MV, AND NOISE WAS CONSTANTLY CONFIRMED IN REAL TIME. THERE IS A PART THAT OVERSENSES EVEN WITH A DULL SENSITIVITY SETTING, THUS IT CHANGED TO AN EXTERNAL CARDIAC PACEMAKER BECAUSE IT WAS A COMPLETE ATRIOVENTRICULAR BLOCK (CHB). AFTER DEVICE EXPLANTATION, PSA MEASUREMENT WAS PERFORMED AND THE RESISTANCE VALUE WAS AROUND 180 OHMS (IT WAS CONFIRMED THERE MIGHT BE A LEAD COATING DAMAGE.) THE OPERATION WAS COMPLETED. THE PHYSICIAN SUSPECTS THE DEVICE MALFUNCTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11229470 ↗
• MalfunctionJan 20, 2021Pacing Intermittently; Pacing Intermittently

  IT WAS REPORTED THAT THIS LEAD WAS EXPLANTED AND REPLACED DUE TO PACING INHIBITION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11205436 ↗
• MalfunctionNov 24, 2020Under-Sensing; Under-Sensing

  AFTER AN IMPLANTATION PERIOD OF APPROX. 67 MONTHS, VENTRICULAR UNDERSENSING WAS REPORTED. THE LEAD WAS EXPLANTED AND REPLACED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10897633 ↗
• MalfunctionNov 20, 2020Impedance Problem; Impedance Problem

  IT WAS REPORTED THAT APPROX. 88 MONTHS AFTER THE IMPLANTATION A LEAD FAILURE ALERT WAS RECEIVED VIA HOME MONITORING. THE PATIENT WAS CALLED IN THE CLINIC FOR A CHECK. THIS RIGHT VENTRICULAR LEAD SWITCHED TO UNIPOLAR. FURTHERMORE THE IMPEDANCE FLUCTUATION WAS NOTED AND OVERSENSING ON THE ATRIAL CHANNEL. LEAD REPLACEMENT IS BEING CONSIDERED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10880191 ↗
• MalfunctionOct 13, 2020Impedance Problem; Impedance Problem

  IT WAS REPORTED THAT APPROX. 48 MONTHS AFTER THE IMPLANTATION, DURING A FOLLOW-UP ERROR MESSAGES WERE SEEN FOR ATRIAL (SAFIO S 53) AND VENTRICULAR (SAFIO S 60) LEADS DUE TO IMPEDANCE ISSUES. IT WAS DECIDED TO EXPLANT THE LEADS AND PERFORM A NEW CRT-P IMPLANT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10671619 ↗
• MalfunctionSep 1, 2020Over-Sensing; Over-Sensing

  AFTER AN IMPLANTATION PERIOD OF APPROX. 26 MONTHS, OVERSENSING ON THE VENTRICULAR CHANNEL WAS REPORTED. THE LEADS WERE EXPLANTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10475727 ↗
• MalfunctionAug 26, 2020Failure to Capture; Failure to Capture

  AFTER AN IMPLANTATION PERIOD OF APPROX. 35 MONTHS, IT WAS REPORTED THAT THE RV LEAD SHOWED NO CAPTURE AT THE PROGRAMMED OUTPUT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10454722 ↗
• MalfunctionJul 16, 2020High Capture Threshold; High Capture Threshold

  IT WAS REPORTED THAT AN INCREASING PACING THRESHOLD WAS OBSERVED APPROX. 58 MONTHS AFTER IMPLANTATION. THE LEAD WAS CAPPED AND LEFT IN SITU. A NEW LEAD WAS IMPLANTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10287081 ↗
• MalfunctionJun 26, 2020Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE LEAD DISLODGED LATER ON THE IMPLANT DAY. A REPOSITION WAS ATTEMPTED BUT NOT SUCCESSFUL. THE LEAD WAS EXCHANGED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10200989 ↗
• MalfunctionJun 19, 2020Device Dislodged or Dislocated; Device Dislodged or Dislocated

  ON (B)(6) 2020, A PATIENT WAS IMPLANTED WITH A NEW PACEMAKER. HOWEVER, DURING FOLLOW-UP BEFORE DISCHARGE ON (B)(6), IT WAS NOTED THAT THE RA AND RV LEADS WERE DISLODGED. ON (B)(6), THE DOCTOR PERFORMED LEAD RE-POSITIONING SURGERY FOR THE PATIENT, BUT THE LEADS DISLODGED AGAIN AND COULD NOT BE FIXED. THE DOCTOR IMPLANTED 2 NEW LEADS FOR THE PATIENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10175541 ↗
• MalfunctionMay 6, 2020Failure to Capture; Ambient Noise Problem; Impedance Problem; Failure to Capture; Ambient Noise Problem; Impedance Problem

  IT WAS REPORTED THAT THERE WAS A DECREASE IN IMPEDANCE DETECTED ON THIS RV LEAD. THE PATIENT EXPERIENCED SLIGHT DIZZINESS. LEAD CHECK REVEALED NOISE AND FAILURE TO CAPTURE. THE LEAD WAS EXPLANTED AND REPLACED.

  Patient problems: Dizziness

  MAUDE report 10028492 ↗
• MalfunctionApr 1, 2020Failure to Capture; Failure to Capture

  AFTER AN IMPLANTATION PERIOD OF APPROX. 69 MONTHS, IT WAS REPORTED THAT THERE WAS A LOSS OF CAPTURE ON THE VENTRICULAR CHANNEL.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9912394 ↗
• MalfunctionFeb 6, 2020Pacing Problem; Pacing Problem

  AFTER AN IMPLANTATION PERIOD OF APPROXIMATELY 58 MONTHS, IT WAS REPORTED THAT A LACK OF STIMULATION WAS OBSERVED. AFTER SWITCHING FROM BIPOLAR TO UNIPOLAR SENSING, THIS BEHAVIOR WAS NO LONGER OBSERVED. THE SERIAL NUMBER OF THE INVOLVED LEAD WAS REPORTED TO US AFTERWARDS.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Known Impact Or Consequence To Patient

  MAUDE report 9679422 ↗
• MalfunctionJan 16, 2020Under-Sensing; High Capture Threshold; Under-Sensing; High Capture Threshold

  IT WAS REPORTED THAT APPROX. 7 MONTHS AFTER IMPLANTATION, AN INCREASE IN THE PACING THRESHOLD AND A SENSING DECREASE WERE OBSERVED. THE LEAD WAS REPLACED WITHOUT COMPLICATIONS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9598905 ↗
• MalfunctionNov 11, 2019Over-Sensing; Over-Sensing

  AFTER AN IMPLANTATION PERIOD OF APPROX. 30 MONTHS, OVERSENSING ON THE VENTRICULAR CHANNEL WAS REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9306716 ↗
• MalfunctionOct 28, 2019Failure to Capture; Over-Sensing; Failure to Capture; Over-Sensing

  IT WAS REPORTED THAT 59 MONTHS AFTER THE IMPLANTATION OF THIS SYSTEM OVERSENSING ON VENTRICULAR AND ATRIAL CHANNELS AND LOSS OF CAPTURE WERE NOTED. THE PACEMAKER AND THE LEADS REMAIN IMPLANTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9245827 ↗