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

Model Number	PM2134
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	02/18/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
Related manufacturer reference number: 2017865-2022-05427, related manufacturer reference number: 2017865-2022-05428.It was reported that the patient presented to the hospital for a check up with signs of infection.Upon examination of the system, it was noted that there was infection which was developed at the pocket incision site.The pacemaker, the right atrial lead and right ventricular lead were explanted on (b)(6) 2022.The patient was in stable condition throughout.
Additional Manufacturer Narrative
It was reported that the product was removed due to infection.During analysis, the interrogation results were normal.Visual screen values were acceptable.Device image download was successful.Preliminary test results were acceptable.A device history record (dhr) review was performed and all required manufacturing processes and inspections steps were confirmed to be completed per the requirements.The device met specifications prior to leaving abbott manufacturing facilities.Review of the sterilization records confirmed normal sterilization cycles for the products.The cause of infection could not be determined.

• Brand Name: SUSTAIN XL DC
• Common Device Name: IMPLANTABLE PACEMAKER PULSE GENERATOR
• 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: sonali arangil ; 15900 valley view court; sylmar, CA 91342
• MDR Report Key: 13766925
• Report Number: 2017865-2022-05426
• Device Sequence Number: 17099375
• Product Code: NVZ
• UDI-Device Identifier: 05414734504720
• UDI-Public: 05414734504720
• 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: 2022
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/27/2022

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: 03/31/2021
• Device Model Number: PM2134
• Device Catalogue Number: PM2134
• Device Lot Number: P000088512
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/07/2022
• 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: 02/21/2022
• Supplement Date Received by Manufacturer: 03/15/2022
• Initial Report FDA Received Date: 03/15/2022
• Supplement Report FDA Received Date: 03/27/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/12/2019
• 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