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

Model Number	PM2134
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Unspecified Infection (1930); Pocket Erosion (2013); Discomfort (2330)
Type of Reportable Event	Serious Injury
Event or Problem Description
Related manufacturer reference number: 2017865-2024-37690.Related manufacturer reference number: 2017865-2024-37691.It was reported that in (b)(6) 2022, the patient felt itchy and pain at the pacemaker pocket site, but no treatment was given.In (b)(6) 2022, the patient came to the hospital due to skin redness, swelling, and erosion at the pocket site.The physician determined a pocket infection and performed a device system explant.There were no adverse health consequences, the patient was stable.
Additional Manufacturer Narrative
The sterilization records were reviewed and no evidence of abnormal sterilization cycle was found.The results of the investigation are inconclusive since the device was not returned for analysis.Based on the information received, the cause of the reported incident could not be conclusively determined.

• Brand Name: SUSTAIN XL DC
• 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: 19040389
• Report Number: 2017865-2024-37689
• Device Sequence Number: 12879558
• Product Code: NVZ
• UDI-Device Identifier: 05414734504720
• UDI-Public: (01)05414734504720(10)P000124577(17)221231
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: P880086
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 04/04/2024

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 12/31/2022
• Device Model Number: PM2134
• Device Lot Number: P000124577
• 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: 03/15/2024
• Initial Report FDA Received Date: 04/04/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/08/2021
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown