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

Model Number	PM2210
Medical Device Problem Codes	Loose or Intermittent Connection (1371); 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	11/20/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the patient presented for a routine generator change out procedure.During the procedure, the pacemaker's atrial set screw could not be engaged with the wrench.Some sort of hard build up was noted on the set screw slot.The atrial lead could not be separated so it was cut and capped.The device and lead were then successfully replaced.There were no patient consequences.
Additional Manufacturer Narrative
The reported event of cannot untighten the a-setscrew to remove the lead was confirmed.The device was returned for analysis.Analysis revealed that calcified blood was filling the a-setscrew inset, preventing the wrench from engaging it.Wrenches cannot penetrate calcified blood so the wrench can only be partially inserted into the setscrew inset.In lab testing the calcified blood was removed from the setscrew inset.The blood came through a hole punched out through the septum by the user of the torque wrench at time of implant.This is consistent with procedural damage, no other anomalies were found.
Additional Manufacturer Narrative
Correction: section b5 - "(b)(6) 2025" should have been included in the initial b5.Section e1 - (b)(6).Section h6 - investigation conclusions should have been "unintended use error caused or contributed to event" instead of "no problem detected".
Event or Problem Description
It was reported that the patient presented for a routine generator change out procedure.During the procedure, the pacemaker's atrial set screw could not be engaged with the wrench.Some sort of hard build up was noted on the set screw slot.The atrial lead could not be separated so it was cut and capped on (b)(6) 2025.The device and lead were then successfully replaced.There were no patient consequences.

• Brand Name: ACCENT DR RF PACEMAKER
• 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: navpreet singh ; 15900 valley view court; sylmar, CA 91342
• MDR Report Key: 23779738
• Report Number: 2017865-2025-1007008
• Device Sequence Number: 9992960
• Product Code: NVZ
• UDI-Device Identifier: 05414734503617
• UDI-Public: (01)05414734503617(10)3553771(17)130531
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: P880086
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2012
• Device Explanted Year: 2025
• 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,Followup
• Report Date (Section B): 04/02/2026

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: 05/31/2013
• Device Model Number: PM2210
• Device Lot Number: 3553771
• 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: 11/20/2025
• Supplement Date Received by Manufacturer: 02/21/2026; 04/01/2026
• Initial Report FDA Received Date: 12/11/2025
• Supplement Report FDA Received Date: 02/27/2026; 04/02/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/13/2011
• 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: TENDRILACTIVE
• Patient Age: 53 YR
• Patient Sex: Male