MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC.(CRM-SUNNYVALE) QUARTET LEAD DOUBLE BEND, 75 CM; PERMANENT PACEMAKER ELECTRODE

Model Number 1457Q/75

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Twiddlers Syndrome (2114)

Event Type  Injury  

Manufacturer Narrative

This product is registered as a combination product.The results of the investigation are inconclusive since the device was not returned for analysis.Based on the information received, the cause of the reported incident could not be conclusively determined.

Event Description

Related manufacturer reference number: 2938836-2020-06736, 2938836-2020-06737, 2938836-2020-06739.It was reported that when the patient presented remotely via merlin.Net transmission, low, out of range, pacing lead impedance was observed on the right atrial lead since (b)(6) 2019.Reproducible noise was also noted in clinic via isometric testing and pocket manipulation.Upon opening the pocket for the lead explant procedure on (b)(6) 2020, twiddler¿s syndrome was found.Right atrial, left ventricular lead, and right ventricular lead were tightly knotted in the pocket.Insulation deformation in helical pattern was noted on the atrial lead.The leads were uncoiled, and the right atrial lead was explanted and replaced.The patient was stable.

• Brand Name: QUARTET LEAD DOUBLE BEND, 75 CM
• Type of Device: PERMANENT PACEMAKER ELECTRODE
• Manufacturer (Section D): ST. JUDE MEDICAL, INC.(CRM-SUNNYVALE); 645 almanor avenue; sunnyvale CA 94085
• Manufacturer (Section G): ST. JUDE MEDICAL, INC.(CRM-SUNNYVALE); 645 almanor avenue; sunnyvale CA 94085
• Manufacturer Contact: elizabeth boltz ; 15900 valley view court; sylmar, CA 91342
• MDR Report Key: 10134266
• MDR Text Key: 194514052
• Report Number: 2938836-2020-06738
• Device Sequence Number: 1
• Product Code: OJX
• UDI-Device Identifier: 05414734510172
• UDI-Public: 05414734510172
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P030054
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 06/09/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/09/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2021
• Device Model Number: 1457Q/75
• Device Catalogue Number: 1457Q/75
• Device Lot Number: A000069410
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/21/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/07/2018
• 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: DURATA STS OPTIM ACTIVE FIXATION, DF-4 CONNECTOR; QUADRA ASSURA MP ICD; TENDRIL STS
• Patient Outcome(s): Required Intervention
• Patient Age: 80 YR