Reply DRRecalls & reported problems

Summary

The FDA's MAUDE database contains 30 adverse event reports that list this exact device (DI 08031527011523), received between May 12, 2017 and May 20, 2021 — classified as 3 deaths, 12 injuries, 15 malfunctions.

The most frequently reported specific device problem is “Incorrect Device Or Component Shipped” (12 reports).

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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 30 reports, in the reporter's own words as published by the FDA.

• InjuryMay 20, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REPORTEDLY, THE PACING SYSTEM WAS EXPLANTED AND REPLACED DUE TO INFECTION.

  Patient problems: Unspecified Infection

  MAUDE report 11856408 ↗
• InjuryOct 9, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REPORTEDLY, ON (B)(6) 2020, EROSION OF THE PACING SYSTEM WAS OBSERVED. THE PACING SYSTEM WAS EXPLANTED ON (B)(6) 2020.

  Patient problems: Pocket Erosion

  MAUDE report 10654418 ↗
• InjuryOct 5, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REPORTEDLY, THE PACING SYSTEM WAS REPLACED DUE TO AN INFECTION.

  Patient problems: Unspecified Infection

  MAUDE report 10626365 ↗
• InjuryApr 29, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REPORTEDLY, THE SUBJECT PACEMAKER WAS EXPLANTED DUE TO INFECTION. PRELIMINARY ANALYSIS REVEALED THAT THE SUBJECT DEVICE HAS BEEN STERILIZED AND RELEASED ACCORDING TO ALL APPLICABLE PROCEDURES.

  Patient problems: Unspecified Infection

  MAUDE report 10008571 ↗
• InjuryDec 24, 2019Premature Discharge of Battery; Premature Discharge of Battery

  REPORTEDLY, BATTERY DEPLETION OCCURRED EARLIER THAN EXPECTED. THE DEVICE SHOULD BE RETURNED FOR ANALYSIS. PRELIMINARY ANALYSIS RESULTS SHOWED THAT BASED ON AVAILABLE DATA, NORMAL BATTERY DEPLETION OCCURRED BASED ON HRS GUIDELINES.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9516069 ↗
• MalfunctionDec 14, 2018Data Problem; Data Problem

  THE SUBJECT PACEMAKER WAS IMPLANTED ON (B)(6) 2017. REPORTEDLY, DURING A FOLLOW-UP PERFORMED ON SEPTEMBER 2017, THE ESTIMATED RESIDUAL LONGEVITY WAS 12 YEARS. THE ESTIMATED RESIDUAL LONGEVITY WAS SUPERIOR TO 8 YEARS IN MAY 2018 AND SUPERIOR TO 7 YEARS ON (B)(6) 2018. THE PATIENT WAS CONCERNED THAT THIS WAS NOT NORMAL BATTERY DEPLETION. IT WAS ALSO OBSERVED THAT THE PERCENTAGE OF VENTRICULAR PACING OF THE PATIENT WAS INITIALLY LOW (ABOUT 1%) AND INCREASED UP TO 96 - 98 % AFTER AN ATRIOVENTRICULAR NODE ABLATION. PRELIMINARY ANALYSIS REVEALED THAT NORMAL BATTERY DEPLETION OCCURRED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8163570 ↗
• MalfunctionJul 18, 2018Output Problem; Output Problem

  IT WAS REPORTEDLY IMPOSSIBLE TO PROGRAM THE DEVICE OUT OF UNIPOLAR PACING AND SENSING MODE. THE REPORTER AT THE HOSPITAL WAS UNSURE IF THE DEVICE WAS PROGRAMMED TO UNIPOLAR BY THE HOSPITAL STAFF OR IF IT WAS RECEIVED IN UNIPOLAR.

  Patient problems: No Information

  MAUDE report 7697539 ↗
• InjuryJul 16, 2018Migration or Expulsion of Device; Adverse Event Without Identified Device or Use Problem; Migration or Expulsion of Device; Adverse Event Without Identified Device or Use Problem

  REPORTEDLY, THE SUBJECT DEVICE WAS REMOVED ON (B)(6) 2018 DUE TO POCKET EROSION. PRELIMINARY ANALYSIS REVEALED THAT THE DEVICE HAS BEEN STERILIZED AND RELEASED ACCORDING TO ALL APPLICABLE PROCEDURES.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7689371 ↗
• MalfunctionJun 22, 2018Electrical /Electronic Property Problem; Electrical /Electronic Property Problem

  REPORTEDLY, ATRIAL AND VENTRICULAR LEAD IMPEDANCE MEASUREMENTS WERE OUT OF RANGE (HIGH) FOR THE PERIOD: (B)(6) 2018 TO (B)(6) 2018 (33 DAYS). PATIENT STATES THAT WAS NOT IN CONTACT WITH ANY EMI SOURCES AND DID NOT UNDERGO TO ANY MEDICAL PROCEDURES. OTHER LEAD IMPEDANCE MEASUREMENTS WERE IN NORMAL RANGE.

  Patient problems: No Information

  MAUDE report 7629454 ↗
• MalfunctionJun 15, 2018Nonstandard Device; Incorrect Device Or Component Shipped; Nonstandard Device; Incorrect Device Or Component Shipped

  REPORTEDLY, ON 8 MAY 2018, (B)(4) WAS INFORMED THAT THE AS-SHIPPED POLARITIES OF THE SUBJECT PACEMAKER WERE UNIPOLAR INSTEAD OF BIPOLAR. AS REPLY PACEMAKERS ARE DESIGNED TO PREVENT POLARITY REPROGRAMMING FROM UNIPOLAR TO BIPOLAR WITHOUT NORMAL LEAD IMPEDANCE MEASUREMENT, THE POLARITY CANNOT BE REPROGRAMMED BEFORE IMPLANTATION.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7604500 ↗
• MalfunctionJun 15, 2018Nonstandard Device; Incorrect Device Or Component Shipped; Nonstandard Device; Incorrect Device Or Component Shipped

  REPORTEDLY, ON (B)(6) 2018, USA CRM TECHNICAL SERVICES WAS INFORMED THAT THE AS-SHIPPED POLARITIES OF THE SUBJECT PACEMAKER WERE UNIPOLAR INSTEAD OF BIPOLAR. AS REPLY PACEMAKERS ARE DESIGNED TO PREVENT POLARITY REPROGRAMMING FROM UNIPOLAR TO BIPOLAR WITHOUT NORMAL LEAD IMPEDANCE MEASUREMENT, THE POLARITY CANNOT BE REPROGRAMMED BEFORE IMPLANTATION.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7604493 ↗
• MalfunctionJun 15, 2018Nonstandard Device; Incorrect Device Or Component Shipped; Nonstandard Device; Incorrect Device Or Component Shipped

  REPORTEDLY, ON (B)(6) 2018, USA CRM TECHNICAL SERVICES WAS INFORMED THAT THE AS-SHIPPED POLARITIES OF THE SUBJECT PACEMAKER WERE UNIPOLAR INSTEAD OF BIPOLAR. AS REPLY PACEMAKERS ARE DESIGNED TO PREVENT POLARITY REPROGRAMMING FROM UNIPOLAR TO BIPOLAR WITHOUT NORMAL LEAD IMPEDANCE MEASUREMENT, THE POLARITY CANNOT BE REPROGRAMMED BEFORE IMPLANTATION.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7604490 ↗
• MalfunctionJun 15, 2018Nonstandard Device; Incorrect Device Or Component Shipped; Nonstandard Device; Incorrect Device Or Component Shipped

  REPORTEDLY, ON (B)(6) 2018, (B)(4) WAS INFORMED THAT THE AS-SHIPPED POLARITIES OF THE SUBJECT PACEMAKER WERE UNIPOLAR INSTEAD OF BIPOLAR. AS REPLY PACEMAKERS ARE DESIGNED TO PREVENT POLARITY REPROGRAMMING FROM UNIPOLAR TO BIPOLAR WITHOUT NORMAL LEAD IMPEDANCE MEASUREMENT, THE POLARITY CANNOT BE REPROGRAMMED BEFORE IMPLANTATION.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7604486 ↗
• MalfunctionMay 16, 2018Incorrect Device Or Component Shipped; Incorrect Device Or Component Shipped

  REPORTEDLY, ON (B)(6) 2018, USA CRM TECHNICAL SERVICES WAS INFORMED THAT THE AS-SHIPPED POLARITIES OF THE SUBJECT PACEMAKER WERE UNIPOLAR INSTEAD OF BIPOLAR. AS REPLY PACEMAKERS ARE DESIGNED TO PREVENT POLARITY REPROGRAMMING FROM UNIPOLAR TO BIPOLAR WITHOUT NORMAL LEAD IMPEDANCE MEASUREMENT, THE POLARITY CANNOT BE REPROGRAMMED BEFORE IMPLANTATION.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7519236 ↗
• MalfunctionMay 16, 2018Incorrect Device Or Component Shipped; Incorrect Device Or Component Shipped

  REPORTEDLY, ON (B)(6) 2018, USA CRM TECHNICAL SERVICES WAS INFORMED THAT THE AS-SHIPPED POLARITIES OF THE SUBJECT PACEMAKER WERE UNIPOLAR INSTEAD OF BIPOLAR. AS REPLY PACEMAKERS ARE DESIGNED TO PREVENT POLARITY REPROGRAMMING FROM UNIPOLAR TO BIPOLAR WITHOUT NORMAL LEAD IMPEDANCE MEASUREMENT, THE POLARITY CANNOT BE REPROGRAMMED BEFORE IMPLANTATION.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7519223 ↗
• MalfunctionMay 16, 2018Incorrect Device Or Component Shipped; Incorrect Device Or Component Shipped

  REPORTEDLY, ON (B)(6) 2018, USA CRM TECHNICAL SERVICES WAS INFORMED THAT THE AS-SHIPPED POLARITIES OF THE SUBJECT PACEMAKER WERE UNIPOLAR INSTEAD OF BIPOLAR. AS REPLY PACEMAKERS ARE DESIGNED TO PREVENT POLARITY REPROGRAMMING FROM UNIPOLAR TO BIPOLAR WITHOUT NORMAL LEAD IMPEDANCE MEASUREMENT, THE POLARITY CANNOT BE REPROGRAMMED BEFORE IMPLANTATION.

  Patient problems: No Information

  MAUDE report 7519221 ↗
• MalfunctionMay 16, 2018Incorrect Device Or Component Shipped; Incorrect Device Or Component Shipped

  REPORTEDLY, ON (B)(6) 2018, USA CRM TECHNICAL SERVICES WAS INFORMED THAT THE AS-SHIPPED POLARITIES OF THE SUBJECT PACEMAKER WERE UNIPOLAR INSTEAD OF BIPOLAR. AS REPLY PACEMAKERS ARE DESIGNED TO PREVENT POLARITY REPROGRAMMING FROM UNIPOLAR TO BIPOLAR WITHOUT NORMAL LEAD IMPEDANCE MEASUREMENT, THE POLARITY CANNOT BE REPROGRAMMED BEFORE IMPLANTATION.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7519215 ↗
• MalfunctionMay 16, 2018Incorrect Device Or Component Shipped; Incorrect Device Or Component Shipped

  REPORTEDLY, ON (B)(6) 2018, USA CRM TECHNICAL SERVICES WAS INFORMED THAT THE AS-SHIPPED POLARITIES OF THE SUBJECT PACEMAKER WERE UNIPOLAR INSTEAD OF BIPOLAR. AS REPLY PACEMAKERS ARE DESIGNED TO PREVENT POLARITY REPROGRAMMING FROM UNIPOLAR TO BIPOLAR WITHOUT NORMAL LEAD IMPEDANCE MEASUREMENT, THE POLARITY CANNOT BE REPROGRAMMED BEFORE IMPLANTATION.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7519211 ↗
• MalfunctionMay 16, 2018Incorrect Device Or Component Shipped; Incorrect Device Or Component Shipped

  REPORTEDLY, ON (B)(6) 2018, USA CRM TECHNICAL SERVICES WAS INFORMED THAT THE AS-SHIPPED POLARITIES OF THE SUBJECT PACEMAKER WERE UNIPOLAR INSTEAD OF BIPOLAR. AS REPLY PACEMAKERS ARE DESIGNED TO PREVENT POLARITY REPROGRAMMING FROM UNIPOLAR TO BIPOLAR WITHOUT NORMAL LEAD IMPEDANCE MEASUREMENT, THE POLARITY CANNOT BE REPROGRAMMED BEFORE IMPLANTATION.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7519157 ↗
• MalfunctionMay 16, 2018Incorrect Device Or Component Shipped; Incorrect Device Or Component Shipped

  REPORTEDLY, ON (B)(6) 2018, USA CRM TECHNICAL SERVICES WAS INFORMED THAT THE AS-SHIPPED POLARITIES OF THE SUBJECT PACEMAKER WERE UNIPOLAR INSTEAD OF BIPOLAR. AS REPLY PACEMAKERS ARE DESIGNED TO PREVENT POLARITY REPROGRAMMING FROM UNIPOLAR TO BIPOLAR WITHOUT NORMAL LEAD IMPEDANCE MEASUREMENT, THE POLARITY CANNOT BE REPROGRAMMED BEFORE IMPLANTATION.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7519149 ↗
• MalfunctionMay 16, 2018Incorrect Device Or Component Shipped; Incorrect Device Or Component Shipped

  REPORTEDLY, ON (B)(6) 2018, USA CRM TECHNICAL SERVICES WAS INFORMED THAT THE AS-SHIPPED POLARITIES OF THE SUBJECT PACEMAKER WERE UNIPOLAR INSTEAD OF BIPOLAR. AS REPLY PACEMAKERS ARE DESIGNED TO PREVENT POLARITY REPROGRAMMING FROM UNIPOLAR TO BIPOLAR WITHOUT NORMAL LEAD IMPEDANCE MEASUREMENT, THE POLARITY CANNOT BE REPROGRAMMED BEFORE IMPLANTATION.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7518409 ↗
• InjuryMar 30, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REPORTEDLY, THE PACEMAKER WAS EXPLANTED AT AN UNKNOWN DATE DUE TO AN INFECTION. THE DEVICE WILL BE RETURNED FOR ANALYSIS.

  Patient problems: Unspecified Infection

  MAUDE report 7384483 ↗
• DeathAug 9, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REPORTEDLY, THE PATIENT IMPLANTED WITH THE SUBJECT PACEMAKER DIED FROM UNKNOWN REASONS ON (B)(6) 2017. IT IS UNKNOWN WHETHER THE PACEMAKER WAS EXPLANTED.

  Patient problems: Death

  MAUDE report 6777223 ↗
• InjuryAug 4, 2017Contamination /Decontamination Problem; Contamination /Decontamination Problem

  INFECTION WAS REPORTED RELATIVE TO THE DEVICE AND ASSOCIATED LEAD (STELA BT45, SN: (B)(4)) . THE SYSTEM WAS EXPLANTED.

  Patient problems: Unspecified Infection

  MAUDE report 6766573 ↗
• InjuryAug 3, 2017Contamination /Decontamination Problem; Adverse Event Without Identified Device or Use Problem; Contamination /Decontamination Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT REPORTEDLY SUFFERED FROM A SEPSIS (PRESENCE OF STAPHYLOCOCCUS AUREAUS) WHICH LED TO THE EXPLANTATION OF THE SUBJECT DEVICE ON (B)(6) 2017.

  Patient problems: Sepsis

  MAUDE report 6763064 ↗

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