MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC.(CRM-SUNNYVALE) QUARTET LEAD SMALL-S, 86 CM; IMPLANTABLE CARDIOVERTER DEFIBRILLATOR

Model Number 1456Q/86

Device Problems Failure to Capture (1081); Device Dislodged or Dislocated (2923)

Patient Problems Twiddlers Syndrome (2114); No Known Impact Or Consequence To Patient (2692)

Event Date 10/12/2019

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

Related manufacturer reference number: 2938836-2019-15088.It was reported that the patient presented in the emergency room after receiving inappropriate shocks.Upon reviewing the transmissions, the right ventricular (rv) lead exhibited loss of capture and oversensing.The rv lead was pulled back to the right atrium and intermittently sensed both atrial and ventricular signals.Lead dislodgement was confirmed on x-ray.Per x-ray, the physician believed that the patient was playing with the device as the left ventricular (lv) and the rv leads were wrapped around the device in the left clavicle region.Loss of capture was noted on both lv and rv leads.During the procedure, the screw of the rv lead would not retract.The rv lead was explanted and replaced.The lv lead was repositioned.The patient was stable before, during, and after the procedure.

• Brand Name: QUARTET LEAD SMALL-S, 86 CM
• Type of Device: IMPLANTABLE CARDIOVERTER DEFIBRILLATOR
• 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 ; 8184932577
• MDR Report Key: 9227729
• MDR Text Key: 163546432
• Report Number: 2938836-2019-15234
• 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
• Report Date: 10/23/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/23/2019
• 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
• Date Manufacturer Received: 10/12/2019
• 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
• Patient Outcome(s): Required Intervention
• Patient Weight: 84