MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC.(CRM-SYLMAR) AV PLUS DX BIFUR BIPOLAR LEAD; IMPLANTABLE PACEMAKER PULSE-GENERATOR

Model Number 1368/58

Device Problem Fracture (1260)

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

Event Date 11/23/2023

Event Type  malfunction  

Event Description

It was reported that during an implant procedure, the lead being used exhibited fracture at the end of the lead electrode.The lead was not used and another lead was used to complete the procedure.The patient was discharged with no further patient consequences.

Manufacturer Narrative

The reported event of ¿a fracture at the end of the electrode¿ was not confirmed.As received, a complete lead was returned in one piece with all the tines intact.Visual and x-ray examination did not find any anomalies on the lead except for the damage found consistent with procedure damage.Electrical testing did not find any indication of conductor fractures or internal shorts.

• Brand Name: AV PLUS DX BIFUR BIPOLAR LEAD
• Type of Device: IMPLANTABLE PACEMAKER PULSE-GENERATOR
• 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: 18509988
• MDR Text Key: 333123714
• Report Number: 2017865-2024-01100
• Device Sequence Number: 1
• Product Code: DXY
• Combination Product (y/n): N
• Reporter Country Code: IS
• PMA/PMN Number: P880086
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 02/21/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/15/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 1368/58
• Device Lot Number: S000089572
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/15/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/22/2023
• 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