MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC.(CRM-SYLMAR) SUSTAIN XL SC; IMPLANTABLE PACEMAKER PULSE GENERATOR

Model Number	PM1134
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Erosion (1750); Pocket Erosion (2013); Discomfort (2330)
Date of Event	06/01/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient presented in hospital in (b)(6) 2021 with pain at their pocket site, it was noted that there was redness and a small amount of fluid exuding locally.Culture testing revealed there was no infection.On (b)(6) 2021, the patient presented to the hospital again with swelling, pain, fluid discharge and local ulceration.There was no allegation of infection.The pacemaker was explanted on (b)(6) 2021.The patient was stable.
Additional Manufacturer Narrative
Analysis was normal.No anomalies were found.Correction - h6 health effect - clinical code should have been pocket erosion not erosion.
Event or Problem Description
New information received notes that the patient received antibiotic treatment in (b)(6) 2021.

• Brand Name: SUSTAIN XL SC
• Common Device Name: IMPLANTABLE PACEMAKER PULSE GENERATOR
• Manufacturer (Section D): ST. JUDE MEDICAL, INC.(CRM-SYLMAR); 15900 valley view court; sylmar CA 91342
• MDR Report Key: 12534930
• Report Number: 2017865-2021-31141
• Device Sequence Number: 13796990
• Product Code: NVZ
• UDI-Device Identifier: 05414734504744
• UDI-Public: 05414734504744
• 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: 2021
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/08/2021

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: 02/28/2022
• Device Model Number: PM1134
• Device Catalogue Number: PM1134
• Device Lot Number: P000107315
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/22/2021
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 09/06/2021
• Supplement Date Received by Manufacturer: 09/24/2021
• Initial Report FDA Received Date: 09/27/2021
• Supplement Report FDA Received Date: 10/08/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention