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

Model Number	PM2134
Medical Device Problem Code	Loose or Intermittent Connection (1371)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/20/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported a patient presented for an implant procedure on (b)(6) 2021.During the operation, the pacemaker screw could not be tightened so the device was exchanged.Post-procedure the patient was stable.
Additional Manufacturer Narrative
Correction: the damage found was sustained during the surgical procedure.Visual inspection of header found ventricular setscrew stripping on the inset which is consistent with user error.
Additional Manufacturer Narrative
The damage found was sustained during the surgical procedure.The lead was otherwise normal.

• 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: 12425188
• Report Number: 2017865-2021-29771
• Device Sequence Number: 16955307
• 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
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/23/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 08/31/2022
• Device Model Number: PM2134
• Device Catalogue Number: PM2134
• Device Lot Number: P000118137
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/14/2021
• 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: 08/20/2021
• Supplement Date Received by Manufacturer: 10/18/2021; 11/23/2021
• Initial Report FDA Received Date: 09/03/2021
• Supplement Report FDA Received Date: 11/07/2021; 11/23/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/26/2021
• 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
• Patient Sex: Unknown