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

Model Number 1688TC/46

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Insufficient Information (3190)

Patient Problem Insufficient Information (4580)

Event Date 12/28/2023

Event Type  Death  

Manufacturer Narrative

The lead was returned due to patient death.As received, only connector portion a partial lead was returned in one piece.Electrical tests did not find any indication of any conductor fractures or internal shorts.During analysis, a failure event was observed which was unrelated to the reported event.Final analysis found a visual inspection of the lead revealed two external insulation abrasions that breached the outer insulation and exposed the outer coil proximal to the suture tie impression.The cause of the external insulation abrasion is consistent with friction to the device can.Further information was requested but not received.

Event Description

Related manufacturer report number: 2017865-2024-33185; related manufacturer report number: 2017865-2024-33187.It was reported that the patient was admitted to the hospital on (b)(6) 2023.It was observed that the patient was in respiratory arrest with cardiac failure.The patient subsequently expired.The physician believed that a malfunction of the implantable cardioverter defibrillator may have caused or contributed to the patient's respiratory arrest.The physician communicated that the device had either not delivered high voltage therapy, or that there were several instances of the device "firing all the time".The device, right atrial, and right ventricular leads were extracted.Respiratory failure was indicated as the patient's primary cause of death, while the secondary cause was cardiac failure.Further information was requested but not received.

Manufacturer Narrative

Correction: medical device problem code.

• Brand Name: TENDRIL SDX LEAD
• 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: 18751745
• MDR Text Key: 335902565
• Report Number: 2017865-2024-33186
• Device Sequence Number: 1
• Product Code: NVN
• Combination Product (y/n): Y
• Reporter Country Code: US
• PMA/PMN Number: P960013
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 04/17/2024

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 Expiration Date: 04/30/2012
• Device Model Number: 1688TC/46
• Device Lot Number: 2787393
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/01/2024
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 02/01/2024
• Initial Date FDA Received: 02/21/2024
• Supplement Dates Manufacturer Received: 03/28/2024
• Supplement Dates FDA Received: 04/18/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/20/2009
• 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
• Patient Outcome(s): Death
• Patient Age: 78 YR
• Patient Sex: Male
• Patient Weight: 61 KG