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

Model Number	PM1160
Medical Device Problem Codes	Loose or Intermittent Connection (1371); Connection Problem (2900)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/02/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Further information requested but was not received.
Event or Problem Description
It was reported that the patient presented for implant procedure.During the procedure, the set screw could not be fixed and the lead could not be locked into the pacemaker's header.The pacemaker was not used and replaced during the procedure.The patient was stable.
Additional Manufacturer Narrative
The reported event of loose or intermittent connection was not confirmed.Final analysis found that as received, the device was above elective replacement indicator (eri).There were no anomalies noted upon visual inspection of the set screw.A lead insertion test was performed and the tested lead was able to be secured to the header and locked with proper torque.Longevity assessment was performed, and the device was in the normal range of operation with appropriate remaining longevity.A device history record (dhr) review was performed and all required manufacturing processes and inspection steps were confirmed to be completed per the requirements.The device met specifications prior to leaving abbott manufacturing facilities.
Additional Manufacturer Narrative
The reported event of loose or intermittent connection was not confirmed.Final analysis found that as received, the device was above elective replacement indicator (eri).There were no anomalies noted upon visual inspection of the set screw.A lead insertion test was performed and the tested lead was able to be secured to the header and locked with proper torque.Longevity assessment was performed, and the device was in the normal range of operation with appropriate remaining longevity.

• Brand Name: ENDURITY SR
• 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: 20670391
• Report Number: 2017865-2024-69654
• Device Sequence Number: 7371575
• Product Code: NVZ
• UDI-Device Identifier: 05414734507042
• UDI-Public: (01)05414734507042(10)P000182334(17)250331
• 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): 01/28/2025

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: 03/31/2025
• Device Model Number: PM1160
• Device Lot Number: P000182334
• Was Device Available for Evaluation?: No
• 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: 10/28/2024
• Supplement Date Received by Manufacturer: 01/24/2025; 01/28/2025
• Initial Report FDA Received Date: 11/12/2024
• Supplement Report FDA Received Date: 01/27/2025; 01/27/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/03/2023
• 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