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

Model Number 1458Q/86

Device Problems Break (1069); Device Dislodged or Dislocated (2923); High Capture Threshold (3266)

Patient Problem Twiddlers Syndrome (2114)

Event Date 11/28/2019

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: 2938836-2019-17121; 2938836-2019-17164.It was reported that when the patient presented for follow up in clinic, high thresholds were noted at right ventricular (rv) and left ventricular(lv) lead.X-ray exhibited dislodgement for both rv and lv lead and device was found to be flipped in pocket with leads braided next to the device.The dislodgement was found to be due to twiddler syndrome.The device was disabled.The patient presented after few days on (b)(6) for lead revision.Twiddler syndrome was confirmed after opening the pocket.The rv lead was found to be braided multiple times after opening the pocket.But no visible damage was noted.The rv lead was explanted and replaced.The lv lead remained implanted with no repositioning or replacement as the thresholds were acceptable.All the leads were connected to the existing device with all the parameters within normal limit.The patient was stable before, during and after the procedure.

Event Description

New information received notes that the left ventricular lead (lv) was also damaged.The device damage was noted due to the twiddler syndrome.

• Brand Name: QUARTET
• Type of Device: PERMANENT PACEMAKER ELECTRODE
• Manufacturer (Section D): ST. JUDE MEDICAL, INC.(CRM-SUNNYVALE); 645 almanor avenue; sunnyvale CA 94085
• MDR Report Key: 9485139
• MDR Text Key: 173364049
• Report Number: 2938836-2019-17122
• Device Sequence Number: 1
• Product Code: NIK
• UDI-Device Identifier: 05414734503198
• UDI-Public: 05414734503198
• Combination Product (y/n): N
• PMA/PMN Number: P030054
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 09/23/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/17/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2021
• Device Model Number: 1458Q/86
• Device Catalogue Number: 1458Q-86
• Device Lot Number: A000061623
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/17/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: DURATA STS; QUADRA ASSURA
• Patient Outcome(s): Required Intervention
• Patient Age: 71 YR