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

Model Number	PM1210
Medical Device Problem Code	Failure to Disconnect (2541)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/28/2023
Type of Reportable Event	Malfunction
Event or Problem Description
Related manufacturer reference numbers: 2017865-2023-50053.It was reported that the patient presented in clinic for generator changeout procedure.During procedure, it was found that the pacemaker setscrew cannot be loosened.The chronic right ventricular (rv) lead was cut and capped, so that the pacemaker could be explanted and replaced.The replacement rv lead exhibited low out-of-range pacing impedance after placement, so the replacement rv lead was not implanted and an alternate near at hand was implanted instead on (b)(6) 2023.The pacemaker was explanted and replaced.There were no patient consequences.
Additional Manufacturer Narrative
The reported event of could not untighten the setscrew to remove the lead was confirmed.The device was received in one piece for analysis.Analysis revealed that calcified blood was filling the setscrew inset.The calcified blood was preventing the wrench from engaging the setscrew.After the calcified blood was removed, a wrench could be fully inserted into the setscrew inset and the setscrew could be untightened normally, and the stuck lead could be removed.No other anomalies were found.

• 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: 17955139
• Report Number: 2017865-2023-50052
• Device Sequence Number: 17463445
• Product Code: NVZ
• UDI-Device Identifier: 05414734502757
• UDI-Public: 05414734502757
• Combination Product (Y/N): N
• Initial Reporter State: LA
• 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: 2023
• 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): 11/29/2023

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: 01/31/2011
• Device Model Number: PM1210
• Device Lot Number: 2826535
• 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: 09/28/2023
• Supplement Date Received by Manufacturer: 11/09/2023
• Initial Report FDA Received Date: 10/18/2023
• Supplement Report FDA Received Date: 11/29/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/13/2009
• 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: Male