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 Codes	Hemorrhage/Blood Loss/Bleeding (1888); Hypersensitivity/Allergic reaction (1907)
Date of Event	09/10/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
Related manufacturer reference number: 2017865-2021-32243, related manufacturer reference number: 2017865-2021-32244.It was reported that the patient was presented with bleeding in the chest pocket a few days after the initial implant of the pacemaker, right atrial (ra) lead, and right ventricular (rv) lead.It was also noted that the ra lead exhibited poor perception.The physician stated that the patient may have been allergic to the pacemaker and leads so they opted to explant the entire system.The patient was recovering.
Event or Problem Description
Additional information received notes that the patient has been discharged.
Additional Manufacturer Narrative
Analysis was normal.No anomalies were found.

• 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
• MDR Report Key: 12554985
• Report Number: 2017865-2021-32242
• Device Sequence Number: 17201538
• 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: 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): 10/18/2021

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: 08/31/2022
• Device Model Number: PM2134
• Device Catalogue Number: PM2134
• Device Lot Number: P000116782
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/01/2021
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 09/13/2021
• Supplement Date Received by Manufacturer: 10/13/2021
• Initial Report FDA Received Date: 09/30/2021
• Supplement Report FDA Received Date: 10/18/2021
• 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; TENDRIL ST; TENDRIL ST
• Outcome Attributed to Adverse Event: Required Intervention