MAUDE Adverse Event Report: ABBOTT SUSTAIN XL DR; Pulse generator, permanent, implantable

Model Number PM2136

Device Problem Incorrect Measurement (1383)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/01/2024

Event Type  Injury  

Event Description

It was reported that during a follow up in clinic, elective replacement indicator (eri) alert was noted on the device, however, the battery voltage was above eri level.Abbott technical support was contacted, the session records were reviewed, and the eri alert was suspected to be a false alert.The device was explanted and replaced to resolve the event.The patient was in stable condition.

• Brand Name: SUSTAIN XL DR
• Type of Device: Pulse generator, permanent, implantable
• Manufacturer (Section D): ABBOTT; 15900 valley view court; sylmar CA 91342
• Manufacturer (Section G): ABBOTT; 15900 valley view court; sylmar CA 91342
• Manufacturer Contact: richard williamson ; 15900 valley view court; sylmar, CA 91342
• MDR Report Key: 18913009
• MDR Text Key: 337768030
• Report Number: 2017865-2024-35090
• Device Sequence Number: 1
• Product Code: NVZ
• UDI-Device Identifier: 05414734504713
• UDI-Public: 05414734504713
• Combination Product (y/n): N
• Reporter Country Code: PO
• PMA/PMN Number: P880086
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/15/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2014
• Device Model Number: PM2136
• Device Lot Number: 3798886
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 03/05/2024
• Initial Date FDA Received: 03/15/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/06/2012
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention