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

Model Number PM2240

Device Problem Failure to Disconnect (2541)

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

Event Date 04/02/2024

Event Type  malfunction  

Event Description

During the generator changes procedure, it was noted the right ventricular (rv) lead was failed to remove form the pacemaker header and the rv lead was damaged.The pacemaker was explanted and replaced.Meanwhile the same rv lead was used.The patient was in stable condition 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 v-lead was pulled apart by the physician while trying to remove it out of the connector.This shows the high abnormal force needed to remove leads from the connectors of the original sbp header design.Actions have already been taken to prevent reoccurrence.A header re-design has been implemented to correct this issue.

• Brand Name: ASSURITY RF 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: 19150134
• MDR Text Key: 340809954
• Report Number: 2017865-2024-39216
• Device Sequence Number: 1
• Product Code: NVZ
• UDI-Device Identifier: 05414734507073
• UDI-Public: (01)05414734507073(10)4657419(17)151231
• 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
• Report Date: 05/02/2024

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: 12/31/2015
• Device Model Number: PM2240
• Device Lot Number: 4657419
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/10/2024
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 04/02/2024
• Initial Date FDA Received: 04/21/2024
• Supplement Dates Manufacturer Received: 05/01/2024
• Supplement Dates FDA Received: 05/02/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/14/2014
• 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 STS LEAD.
• Patient Sex: Female