MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC.(CRM-SYLMAR) ACCENT SR RF; PULSE GENERATOR, PERMANENT, IMPLANTABLE

Model Number	PM1210
Medical Device Problem Codes	Failure to Disconnect (2541); Contamination of Device Ingredient or Reagent (2901)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/04/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the patient presented for an implant procedure.During the procedure, it was noted that the pacemaker was unable to remove the setscrew from the header due to the foreign material was noted.The pacemaker was explanted and replaced.The patient was in stable condition throughout the procedure.
Additional Manufacturer Narrative
The reported event of could not untighten setscrew to remove the leads was confirmed.Analysis revealed that calcified blood and pieces of the septum was filling the setscrew insets.The calcified blood and the pieces of septum were preventing the wrench from engaging the setscrew inset to untighten the setscrews.Also, the physician stripped the set screw preventing it to be tightened.The physician was incorrectly inserting the torque wrench into the setscrew inset in multiple ways.The incorrect wrench insertions damaged the setscrew.The setscrew could not be tightened because of a combination of incorrect wrench insertions, damage to it by the user/physician in the field and foreign material/contamination found in the set screw.No device anomalies were found.The setscrew anomaly was consistent with having occurred during the procedure.

• Brand Name: ACCENT SR RF
• Common Device Name: PULSE GENERATOR, PERMANENT, IMPLANTABLE
• 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: richard williamson ; 15900 valley view court; sylmar, CA 91342
• MDR Report Key: 18523488
• Report Number: 2017865-2024-01339
• Device Sequence Number: 15475716
• Product Code: NVZ
• UDI-Device Identifier: 05414734502757
• UDI-Public: 05414734502757
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: P880086
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2010
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/29/2024

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: 01/31/2012
• Device Model Number: PM1210
• Device Lot Number: 3164189
• 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: 01/04/2024
• Supplement Date Received by Manufacturer: 01/28/2024
• Initial Report FDA Received Date: 01/17/2024
• Supplement Report FDA Received Date: 01/29/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/01/2010
• 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: RIGHT VENTRICULAR LEAD
• Patient Sex: Male