Sustain™ PM1134Recalls & reported problems

Summary

The FDA's MAUDE database contains 14 adverse event reports that list this exact device (DI 05414734504744), received between Mar 11, 2019 and Jan 15, 2026 — classified as 9 injuries, 5 malfunctions.

The most frequently reported specific device problem is “Misconnection” (2 reports).

9 other recalls cover devices cleared under the same FDA submission (P880086); 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 14 most recent of 14 reports, in the reporter's own words as published by the FDA.

• InjuryJan 15, 2026Therapy Delivered to Incorrect Body Area; Unexpected Mode Switch

  IT WAS REPORTED THAT THE PATIENT PRESENTED TO THE HOSPITAL AFTER EXPERIENCING INAPPROPRIATE STIMULATION IN THE POCKET AREA. UPON INTERROGATION, THE PACEMAKER WAS FOUND IN BACKUP MODE. THE PACEMAKER WAS EXPLANTED AND REPLACED. THE PATIENT WAS STABLE.

  Patient problems: Discomfort

  MAUDE report 24082656 ↗
• InjuryJun 14, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT'S PACEMAKER WAS INFECTED. THE PACEMAKER WAS EXPLANTED. NO ADDITIONAL INFORMATION WAS REPORTED.

  Patient problems: Unspecified Infection

  MAUDE report 17131547 ↗
• InjuryMar 13, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT PRESENTED IN THE CLINIC DUE TO PACEMAKER POCKET INFECTION AND EROSION. IT WAS NOTED THAT THE PACEMAKER WAS ERODED AND VISIBLE THROUGH THE PACEMAKER POCKET. THE PACEMAKER WAS EXPLANTED DUE TO PACEMAKER POCKET INFECTION AND EROSION. THE PATIENT'S CONDITION WAS STABLE.

  Patient problems: Pocket Erosion; Unspecified Infection

  MAUDE report 16535111 ↗
• InjuryOct 18, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT PRESENTED IN THE HOSPITAL DUE TO PACEMAKER POCKET INFECTION. IT WAS NOTED THAT THE PACEMAKER WAS ERODED THROUGH THE PACEMAKER POCKET AND POCKET INFECTION WAS DISCOVERED. THE PACEMAKER WAS EXPLANTED DUE TO PACEMAKER POCKET INFECTION AND EROSION. THE PATIENT'S CONDITION WAS STABLE.

  Patient problems: Pocket Erosion; Unspecified Infection

  MAUDE report 15623601 ↗
• MalfunctionSep 28, 2022Loose or Intermittent Connection; Loose or Intermittent Connection

  IT WAS REPORTED THAT THE PATIENT PRESENTED FOR AN IMPLANT PROCEDURE. DURING THE PROCEDURE, IT WAS NOTED THAT THE PACEMAKER SETSCREW WAS FAILING TO BE TIGHTENED. THE PACEMAKER WAS NOT USED. THE PHYSICIAN CONTINUED TO USE THE SECOND PACEMAKER AND COMPLETED THE PROCEDURE. THE PATIENT WAS IN STABLE CONDITION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15500501 ↗
• InjurySep 17, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  RELATED MANUFACTURER REFERENCE NUMBER: 2017865-2022-38457. IT WAS REPORTED THAT THE PATIENT PRESENTED TO THE HOSPITAL FOR OUTPATIENT REVIEW. UPON EXAMINATION, THE PACEMAKER POUCH WAS FOUND TO BE RUPTURED AND INFECTED. THE ENTIRE PACEMAKER SYSTEM WAS EXPLANTED DUE TO INFECTION. THE PATIENT'S CONDITION WAS STABLE.

  Patient problems: Unspecified Infection; Wound Dehiscence

  MAUDE report 15443173 ↗
• InjuryAug 24, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  RELATED MANUFACTURER REFERENCE NUMBER: 2017865-2022-21284. IT WAS REPORTED THAT THE PATIENT PRESENTED FOR A FOLLOW-UP IN CLINIC WITH THE SKIN OF THE DEVICE POCKET APPEARING SWOLLEN. THE PACEMAKER AND RIGHT VENTRICULAR LEAD WERE EXPLANTED AND REPLACED DUE TO INFECTION. THE PATIENT WAS IN STABLE CONDITION.

  Patient problems: Unspecified Infection

  MAUDE report 15280808 ↗
• MalfunctionJan 10, 2022Pacemaker Found in Back-Up Mode; Pacemaker Found in Back-Up Mode

  IT WAS REPORTED THAT THE PATIENT PRESENTED IN CLINIC FOR AN INITIAL IMPLANT. DURING THE PROCEDURE, THE PHYSICIAN NOTED THE PACEMAKER WAS IN BACKUP MODE. THE PACEMAKER WAS REPLACED. THE PATIENT WAS STABLE THROUGHOUT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13213856 ↗
• InjurySep 27, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  NEW INFORMATION RECEIVED NOTES THAT THE PATIENT RECEIVED ANTIBIOTIC TREATMENT IN (B)(6) 2021.

  Patient problems: Discomfort; Erosion; Pocket Erosion

  MAUDE report 12534930 ↗
• InjurySep 13, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  RELATED MANUFACTURER REFERENCE NUMBER: 2017865-2021-30262. IT WAS REPORTED THAT THE PATIENT PRESENTED EXPERIENCING PAIN DUE TO A SWOLLEN WOUND. UPON INSPECTION, IT WAS NOTED THAT THE PATIENT HAD AN INFECTION AND EROSION. THE PACEMAKER WAS EXPLANTED AND A PORTION OF THE RIGHT VENTRICULAR LEAD WAS REMOVED, WHILE THE REST REMAINED IMPLANTED. THE PATIENT WAS IN STABLE CONDITION.

  Patient problems: Discomfort; Pocket Erosion; Unspecified Infection

  MAUDE report 12460132 ↗
• MalfunctionJun 15, 2021No Pacing; No Pacing

  IT WAS REPORTED THAT DURING INITIAL IMPLANT, A PATIENT'S PACEMAKER EXHIBITED NO LOW VOLTAGE OUTPUTS EVEN AFTER MULTIPLE ATTEMPTS TO PACE. THE PACEMAKER WAS NOT USED AND ANOTHER PACEMAKER WAS USED TO COMPLETED THE PROCEDURE. THE PATIENT WAS STABLE THROUGHOUT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12005406 ↗
• InjuryJan 4, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  RELATED MANUFACTURER REFERENCE NUMBER: 2017865-2021-00144. IT WAS REPORTED THAT THE PATIENT WAS ADMITTED TO THE HOSPITAL DUE TO POCKET RUPTURE AND PACEMAKER EXPOSURE. AFTER EXAMINATION, IT WAS CONFIRMED THAT THE PACEMAKER POCKET WAS INFECTED AND THE POCKET WAS ULCERATED AT THE SAME TIME. THE PHYSICIAN CONSIDERED THAT THE POSSIBLE CAUSE OF INFECTION IS THAT THE PATIENT IS TOO THIN. THE SYSTEM WAS EXPLANTED ON (B)(6) 2020 AND REPLACED ON (B)(6) 2020. THE PATIENT WAS STABLE.

  Patient problems: Erosion; Pocket Erosion; Unspecified Infection

  MAUDE report 11113922 ↗
• MalfunctionApr 9, 2020Misconnection; Misconnection

  IT WAS REPORTED THAT DURING PROCEDURE, THE NEW PACEMAKER WAS ATTEMPTED BE IMPLANTED HOWEVER, THE SET SCREW WAS UNABLE TO BE FIXED AND EXHIBITED A CONNECTION PROBLEM. THE DEVICE WAS REMOVED AND REPLACED. THE PATIENT WAS IN STABLE CONDITION.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9946471 ↗
• MalfunctionMar 11, 2019Misconnection; Misconnection

  IT WAS REPORTED THE PATIENT PRESENTED THE DAY FOLLOWING INITIAL IMPLANT OF A RIGHT VENTRICULAR LEAD. THE LEAD WAS OBSERVED TO BE DISLODGED. DURING AN OPERATION TO REVISE THE LEAD, THE SETSCREW OF THE PACEMAKER COULD NOT BE LOOSENED. THE PACEMAKER AND LEAD WERE EXPLANTED. THE PATIENT WAS IN STABLE CONDITION FOLLOWING THE PROCEDURE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8410345 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under P880086. One submission often covers many models, so check the product and lot details in each record.

• Z-1497-2022 · Jun 17, 2022 · Open, Classified
  Merlin.net model MN5000 Software
• Z-1496-2022 · Jun 17, 2022 · Open, Classified
  Merlin 2 PCS MER37000 programmer Model MER3400 software
• Z-1495-2022 · Jun 17, 2022 · Open, Classified
  Merlin PCS 3650 programmer Model 3330 software
• Z-0429-2012 · Sep 23, 2011 · Terminated
  Implantable Pacemaker Accent DR models PM2110 and PM2210 St. Jude Medical pacemakers monitor and regulate a patient's heart rate with pacing therapy.
• Z-0430-2012 · Sep 23, 2011 · Terminated
  Anthem CRT-P models PM3110 and PM3210 St. Jude Medical pacemakers monitor and regulate a patient's heart rate with pacing therapy.
• Z-0298-2007 · Oct 6, 2006 · Terminated
  St. Jude Medical Identity SR Model 5172, Identity DR Model 5370, & Identity XL DR Model 5376; Pulse Generators (pacemakers)
• Z-0296-2007 · Oct 6, 2006 · Terminated
  St. Jude Medical APS III Programmer, used in combination with St. Jude Medical bradycardia and tachycardia devices. Model 3500/3510
• Z-0297-2007 · Oct 6, 2006 · Terminated
  St. Jude Medical Merlin PCS Programmer, used in combination with St. Jude Medical bradycardia and tachycardia devices. Model 3650
• Z-0052-04 · Jul 31, 2003 · Terminated
  Pulse Generator