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); Unspecified Infection (1930); Pocket Erosion (2013)
Date of Event	12/15/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
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.
Event or Problem Description
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.
Additional Manufacturer Narrative
Analysis was normal.No anomalies were found.

• 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: 11113922
• Report Number: 0002017865-2021-00143
• Device Sequence Number: 3609090
• 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: 2020
• Device Explanted Year: 2020
• 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): 02/12/2021

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: 09/30/2020
• Device Model Number: PM1134
• Device Catalogue Number: PM1134
• Device Lot Number: P000078093
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/04/2021
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 12/19/2020
• Supplement Date Received by Manufacturer: 01/22/2021
• Initial Report FDA Received Date: 01/04/2021
• Supplement Report FDA Received Date: 02/12/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: TENDRIL ST; TENDRIL ST
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention