MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC.(CRM-SYLMAR) SUSTAIN XL DR; Pulse generator, permanent, implantable

Model Number	PM2136
Medical Device Problem Codes	Premature Discharge of Battery (1057); Pacemaker Found in Back-Up Mode (1440); Battery Problem (2885)
Health Effect - Clinical Code	Dizziness (2194)
Date of Event	10/06/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient presented in the hospital after experiencing dizziness and a fall at home.Upon interrogation, the pacemaker was in backup vvi mode and exhibited premature battery depletion and increased battery impedance.The pacemaker was explanted and replaced.The patient was in stable condition.

• Brand Name: SUSTAIN XL DR
• Common Device Name: Pulse generator, permanent, implantable
• Manufacturer (Section D): ST. JUDE MEDICAL, INC.(CRM-SYLMAR); 15900 valley view court; sylmar CA 91342
• Manufacturer (Section G): ST. JUDE MEDICAL, INC.(CRM-SYLMAR); 15900 valley view court; sylmar CA 91342
• Manufacturer Contact: richard williamson ; 15900 valley view court; sylmar, CA 91342
• MDR Report Key: 18026306
• Report Number: 2017865-2023-50933
• Device Sequence Number: 12660860
• Product Code: NVZ
• UDI-Device Identifier: 05414734504713
• UDI-Public: 05414734504713
• Combination Product (Y/N): N
• Initial Reporter Country: SF
• PMA/510(K) Number: P880086
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2013
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility,Company Representative,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 10/27/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 03/31/2015
• Device Model Number: PM2136
• Device Lot Number: 4280636
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/06/2023
• Initial Report FDA Received Date: 10/27/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/03/2013
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: RIGHT VENTRICULAR LEAD
• Patient Sex: Unknown