MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC.(CRM-SYLMAR) TENDRIL STS; NO MATCH

Model Number 2088TC/52

Device Problems Failure to Capture (1081); Device Sensing Problem (2917); Impedance Problem (2950)

Patient Problem Discomfort (2330)

Event Date 03/19/2024

Event Type  Injury  

Event Description

It was reported that the patient presented for an in-clinic follow-up experiencing discomfort.Upon review, it was noted that the atrial lead exhibited failure to capture, varying impedance, and poor sensing.The atrial lead was explanted and replaced.Patient was in stable condition.

Manufacturer Narrative

The reported events of failure to capture, varying low voltage impedance and unspecified sensing issue were confirmed.As received, a complete lead was returned in one piece.Visual inspection of the lead found clavicle crush damaging the outer insulation and the outer coil flattened distal to the suture sleeve tied down impression.Electrical testing performed found an internal shorting due to rib clavicle rush damage.Destructive analysis found the inner insulation was damaged in the clavicle damage region.The cause of the reported events was isolated to a clavicle crush damage.

• Brand Name: TENDRIL STS
• Type of Device: NO MATCH
• 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: 19041488
• MDR Text Key: 339379223
• Report Number: 2017865-2024-37457
• Device Sequence Number: 1
• Product Code: NVN
• UDI-Device Identifier: 05414734502887
• UDI-Public: (01)05414734502887(10)P000157304(17)251031
• Combination Product (y/n): Y
• Reporter Country Code: CH
• PMA/PMN Number: P960013
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative,Distributor
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 05/03/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 2088TC/52
• Device Lot Number: P000157304
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 03/19/2024
• Initial Date FDA Received: 04/04/2024
• Supplement Dates Manufacturer Received: 04/16/2024
• Supplement Dates FDA Received: 05/03/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/08/2022
• 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: ENDURITY MRI; TENDRIL STS
• Patient Outcome(s): Required Intervention