SELECTSECURE™ 383074 (UDI 00643169535855)Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00643169535855), received between Aug 10, 2017 and Nov 26, 2021 — classified as 1 death, 3 injuries, 2 malfunctions.

The most frequently reported specific device problem is “High Capture Threshold” (2 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• InjuryNov 26, 2021High Capture Threshold; High Capture Threshold

  IT WAS REPORTED THAT THE IMPLANTABLE PULSE GENERATOR (IPG) EXHIBITED PREMATURE BATTERY DEPLETION. IT WAS ALSO REPORTED THAT HIGH THRESHOLDS WERE NOTED ON THE RIGHT VENTRICULAR (RV) HIS- BUNDLE LEAD. THE IPG  WAS EXPLANTED WHILE THE RV HIS BUNDLE LEAD WAS CAPPED AND BOTH WERE REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12877857 ↗
• MalfunctionAug 12, 2021Under-Sensing; Under-Sensing

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED A FALL. IT WAS ALSO NOTED THAT BOTH THE RIGHT ATRIAL (RA) LEAD AND RIGHT VENTRICULAR (RV) LEAD WERE UNDERSENSING. BOTH LEADS REMAINS IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Fall

  MAUDE report 12311700 ↗
• MalfunctionMay 7, 2021Over-Sensing; Over-Sensing

  IT WAS REPORTED THAT THE PATIENT PRESENTED TO HOSPITAL WITH WEAKNESS. THE RIGHT VENTRICULAR (RV) HIS BUNDLE LEAD EXHIBITED HIGH V-V SENSING INTEGRITY COUNTER (SIC) COUNT. THE RV HIS LEAD REMAINS IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Muscle Weakness/Atrophy

  MAUDE report 11788775 ↗
• InjuryJul 17, 2018Pacing Problem; High Capture Threshold; High Capture Threshold

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD PACING THRESHOLD INCREASED, AND THERE WAS NO CHANGE IN PACING IMPEDANCE OR R-WAVE AMPLITUDE. THE DECISION WAS MADE TO ADD A LEAD NEAR THE ORIGINAL AND KEEP THE RV LEAD CONNECTED TO A CARDIAC RESYNCHRONIZATION THERAPY PACEMAKER (CRT-P) DEVICE IN ORDER TO MAINTAIN MAGNETIC RESONANCE IMAGING (MRI) COMPATIBILITY. THE LEAD WAS PLACED IN THE LEFT VENTRICULAR (LV) LEAD PORT AND IS CURRENTLY NOT BEING UTILIZED FOR PACING. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Code Available; No Known Impact Or Consequence To Patient

  MAUDE report 7695230 ↗
• DeathMar 22, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE IMPLANTABLE PULSE GENERATOR (IPG) SYSTEM WAS EXPLANTED AND REPLACED DUE TO INFECTION. IT WAS NOTED THAT THE PATIENT ALSO RECEIVED ANTIBIOTIC TREATMENT. IT WAS FURTHER REPORTED THAT THE PATIENT'S INFECTION CONTINUED DESPITE TREATMENT AND THE PATIENT SUBSEQUENTLY DIED.

  Patient problems: Death; Unspecified Infection

  MAUDE report 7364028 ↗
• InjuryAug 10, 2017Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED BY THE PATIENT THAT ONE OF THE LEADS HAD DISCONNECTED FROM THE HEART ON THE DAY IT WAS IMPLANTED, AND DISCONNECTED AGAIN THE DAY AFTER. IN ADDITION, THE PATIENT STATED THAT THE DOCTOR DID AN ABLATION PROCEDURE TWICE, AND THE LEAD WOULD NOT STAY. FOLLOW-UP WITH THE CLINIC INDICATED THAT THE LEAD HAD DISLODGED DUE TO PATIENT ANATOMY WHILE THE PHYSICIAN ATTEMPTED TO IMPLANT AT THE PATIENT'S HIS BUNDLE. THE LEAD REMAINS IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6786534 ↗