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	04/05/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the patient presented to the hospital for a pacemaker implant procedure on (b)(6) 2022.While attempting to implant the pacemaker, it was noted that there was set screw issue.The set screw could not be tightened and has a loose connection.After multiple failed attempts, the whole system was removed without further incident in the same procedure.The patient was in stable condition.
Additional Manufacturer Narrative
The reported event of the wrench did not click when tightening the ventricular setscrew was confirmed.Analysis revealed the user of the torque wrench was incorrectly inserting the wrench at angles instead of straight down and also not aligning the wrench to go into the hex setscrew inset.The multiple incorrect wrench insertion attempts caused excessive septum punch-outs that landed in and filled the setscrew inset.The excess septum punch-outs limited wrench insertion into the setscrew inset and caused the wrench to slip and strip portions of the inset.Under these conditions caused by the user, the setscrew could not be tightened which means the wrench will not click.The problem is related to the user's incorrect use of the torque wrench.

• 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: 14442505
• Report Number: 2017865-2022-10469
• Device Sequence Number: 4310479
• 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: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/23/2022

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: 12/31/2022
• Device Model Number: PM2134
• Device Catalogue Number: PM2134
• Device Lot Number: P000124430
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• 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: 04/29/2022
• Supplement Date Received by Manufacturer: 08/15/2022
• Initial Report FDA Received Date: 05/19/2022
• Supplement Report FDA Received Date: 08/23/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/05/2021
• 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
• Concomitant Medical Products and Therapy/Usage Dates: TENDRIL; TENDRIL
• Patient Sex: Unknown