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

Model Number	PM2160
Medical Device Problem Code	Loose or Intermittent Connection (1371)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/28/2025
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 there was no clicking sound from the set screw when the lead was connected to the pacemaker, and the connection appeared to be loose.The pacemaker was not used and replaced during the procedure.The patient was stable.
Additional Manufacturer Narrative
The reported event of the wrench did not click, and the lead could be pulled out of the connector was confirmed.Analysis revealed that the v-setscrew had been screwed out of the connector block socket by the physician most likely making too turns in the reverse direction.Once the setscrew is out of the socket and falls out of position it cannot be engaged by the wrench again.Therefore, the wrench turned without clicking and the lead could be pulled out because the torque wrench could not re-engage the setscrew to tighten it.Lab testing verified the v-setscrew was normal and could be tightened with the wrench clicking.The problem is related to the user¿s incorrect use of the torque wrench.

• Brand Name: ENDURITY DR
• 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: 22812588
• Report Number: 2017865-2025-97784
• Device Sequence Number: 18318746
• Product Code: NVZ
• UDI-Device Identifier: 05414734507059
• UDI-Public: (01)05414734507059(10)P000189972(17)250731
• 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,Followup
• Report Date (Section B): 03/09/2026

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: 07/31/2025
• Device Model Number: PM2160
• Device Lot Number: P000189972
• 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: 07/28/2025
• Supplement Date Received by Manufacturer: 10/10/2025; 03/06/2026
• Initial Report FDA Received Date: 08/14/2025
• Supplement Report FDA Received Date: 10/12/2025; 03/09/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/05/2024
• 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