Reply SRRecalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 08031527012247), received between Aug 8, 2018 and Dec 2, 2020 — classified as 2 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Failure to Capture” (1 report).

1 other recall cover devices cleared under the same FDA submission (P950029); they may or may not involve this specific model.

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 16, 2026.

Most reported problems

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjuryDec 2, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REPORTEDLY, THE PACING SYSTEM WAS EXPLANTED DUE TO INFECTION.

  Patient problems: Unspecified Infection

  MAUDE report 10933932 ↗
• InjuryNov 17, 2020Failure to Capture; Program or Algorithm Execution Problem; Program or Algorithm Execution Failure; Failure to Capture; Program or Algorithm Execution Problem; Program or Algorithm Execution Failure

  REPORTEDLY, THE PATIENT WAS ADMITTED TO THE HOSPITAL ON (B)(6) 2020 DUE TO A SYNCOPE. UPON DEVICE INTERROGATION, LOSS OF CAPTURE WAS OBSERVED IN SEVERAL EPISODES RECORDED IN THE DEVICE MEMORY. THE PHYSICIAN DECIDED TO PROGRAM THE AUTOMATIC VENTRICULAR THRESHOLD FEATURE. ABSENCE OF VENTRICULAR CAPTURE WITH AN OUTPUT AT 4 V WAS OBSERVED DURING THE CALIBRATION PHASE, ALTHOUGH THE VENTRICULAR CAPTURE THRESHOLD WAS MEASURED AT 0.75 V ¿ 1 V/0.5 MS MANUALLY. IT WAS REPORTED THAT A RECENT FALL COULD HAVE DAMAGED THE VENTRICULAR LEAD, THOUGH IT COULD NOT BE CONFIRMED ON THE X-RAY OR BY REVIEWING THE LEAD IMPEDANCE CURVE. ADDITIONALLY, LOSS OF CAPTURE COULD NOT BE REPRODUCED DURING THE FOLLOW-UP. IT WAS ONLY OBSERVED IN SPECIFIC POSTURAL CONDITIONS. IT WAS DECIDED TO REPLACE THE VENTRICULAR LEAD. PRELIMINARY ANALYSIS REVEALED THAT THE VENTRICULAR AUTO-THRESHOLD FAILED BECAUSE CALIBRATION PHASE CRITERIA WERE NOT MET.

  Patient problems: Syncope

  MAUDE report 10852990 ↗
• MalfunctionAug 9, 2018Output Problem; Output Problem

  REPORTEDLY, THE SUBJECT PACEMAKER WAS RETURNED FROM THE CUSTOMER, WHO DID NOT WANT TO KEEP IT IN CONSIGNMENT BECAUSE IT WAS IN UNIPOLAR CONFIGURATION.

  Patient problems: No Information

  MAUDE report 7766713 ↗
• MalfunctionAug 8, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REPORTEDLY, THE SUBJECT DEVICE WAS IMPLANTED ON (B)(6) 2018 AFTER IT PASSED THE USE-BY-DATE ((B)(6) 2018). PRELIMINARY ANALYSIS DID NOT REVEAL ANY TECHNICAL AND SAFETY ISSUE.

  Patient problems: No Information

  MAUDE report 7762174 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under P950029. One submission often covers many models, so check the product and lot details in each record.

• Z-2235-2009 · Sep 23, 2008 · Terminated
  Sorin Group Reply DR Rate responsive dual-chamber pacemaker. Made in Italy by: Sorin BioMedica CRM S.r.l., Via Crescentino s.n., 13040 Saluggia (VC) Italy. ELA Medical, Inc., 14