MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC.(CRM-SYLMAR) QUARTET LEAD SMALL-S, 86 CM; PERMANENT PACEMAKER ELECTRODE

Model Number 1456Q/86

Device Problem Device Dislodged or Dislocated (2923)

Patient Problem Twiddlers Syndrome (2114)

Event Date 11/10/2019

Event Type  Injury  

Manufacturer Narrative

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

Manufacturer report number: 2017865-2019-17014.Manufacturer report number: 2017865-2019-17015.Manufacturer report number: 2017865-2019-17016.It was reported that the patient presented in the emergency room on (b)(6) 2019 after receiving inappropriate shocks.Upon review of remote transmission, it was revealed that the implantable cardioverter defibrillator had delivered multiple inappropriate shocks due to double counting of the ventricular channel.Xray revealed that the atrial lead had dislodged into the right ventricle and the right ventricular lead had pulled back and was able to detect both atrial and ventricular signals.Device therapy was programmed off to prevent the patient from receiving further inappropriate shocks.The patient presented for lab revision procedure on (b)(6) 2019.Under xray the right atrial lead, right ventricular lead, and left ventricular lead were sitting in the right atrium, at the valve.The physician specified that the patient has dementia and believed that the patient was playing with the device.The right atrial lead, right ventricular lead, and left ventricular lead were revised successfully during procedure.The patient was stable post procedure.

• Brand Name: QUARTET LEAD SMALL-S, 86 CM
• Type of Device: PERMANENT PACEMAKER ELECTRODE
• 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: elizabeth boltz ; 15900 valley view court; sylmar, CA 91342
• MDR Report Key: 9371323
• MDR Text Key: 167865520
• Report Number: 2017865-2019-17017
• Device Sequence Number: 1
• Product Code: NIK
• UDI-Device Identifier: 05414734510158
• UDI-Public: 05414734510158
• 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,Followup
• Report Date: 12/05/2019

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: 07/31/2022
• Device Model Number: 1456Q/86
• Device Catalogue Number: 1456Q/86
• Device Lot Number: A000085058
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 11/10/2019
• Initial Date FDA Received: 11/25/2019
• Supplement Dates Manufacturer Received: 12/05/2019
• Supplement Dates FDA Received: 12/05/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/21/2019
• 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 MRI
• Patient Outcome(s): Required Intervention
• Patient Age: 69 YR