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

Model Number PM2160

Device Problem Failure to Disconnect (2541)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/15/2024

Event Type  malfunction  

Event Description

It was reported that the patient presented to the hospital for a generator change-out procedure.During the procedure, it was noted that the right ventricular (rv) lead was stuck in the header of the pulse generator.The header was drilled through, and the rv lead was managed to be removed.The pulse generator was replaced successfully.The patient was stable throughout the procedure.

Manufacturer Narrative

The reported event of could not remove the ventricular lead from the header was confirmed.Analysis revealed this device has the original scalable brady pacemaker (sbp) header design, which is known to have lead insertion and removal difficulties.This caused the v-lead to become stuck and un-removeable from the header.This anomaly with the header caused the physician to break the header apart in order to remove the lead.This shows the high abnormal force needed to remove leads from the connectors of the original sbp header design.

• Brand Name: ENDURITY DR
• Type of Device: 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: 18794594
• MDR Text Key: 336447536
• Report Number: 2017865-2024-33642
• Device Sequence Number: 1
• Product Code: NVZ
• UDI-Device Identifier: 05414734507059
• UDI-Public: 05414734507059
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P880086
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 05/23/2024

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
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2015
• Device Model Number: PM2160
• Device Lot Number: 4573252
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 02/15/2024
• Initial Date FDA Received: 02/27/2024
• Supplement Dates Manufacturer Received: 05/16/2024; 05/23/2024
• Supplement Dates FDA Received: 05/16/2024; 05/23/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/17/2014
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: TENDRIL.; TENDRIL.
• Patient Age: 60 YR
• Patient Sex: Male