MAUDE Adverse Event Report: ABBOTT 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 Problem Twiddlers Syndrome (2114)

Event Date 05/06/2019

Event Type  Injury  

Manufacturer Narrative

Investigation results will be provided in the final report.

Event Description

During follow-up, loss of capture and dislodgment were observed on the left ventricular lead due to twiddler's syndrome.The lead was explanted and replaced to resolve the event.The patient was in stable condition.

Manufacturer Narrative

A complete lead was returned for analysis.The s-curve hump height was measured within specification.Electrical testing did not find any indication of conductor fractures or internal shorts.Visual examination did not find any anomalies.The reported events of loss of capture and lead dislodgement due to twiddler¿s syndrome were not confirmed.

• Brand Name: QUARTET LEAD SMALL-S, 86 CM
• Type of Device: IMPLANTABLE CARDIOVERTER DEFIBRILLATOR
• Manufacturer (Section D): ABBOTT; 15900 valley view court; sylmar CA 91342
• Manufacturer (Section G): ABBOTT; 15900 valley view court; sylmar CA 91342
• Manufacturer Contact: elizabeth boltz ; 15900 valley view court; sylmar, CA 91342 ; 8184932577
• MDR Report Key: 8586602
• MDR Text Key: 144277357
• Report Number: 2017865-2019-06534
• Device Sequence Number: 1
• Product Code: NIK
• UDI-Device Identifier: 05414734510158
• UDI-Public: 05414734510158
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: P030054
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 06/24/2019

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: 07/31/2021
• Device Model Number: 1456Q/86
• Device Catalogue Number: 1456Q/86
• Device Lot Number: A000064041
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/23/2019
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 05/06/2019
• Initial Date FDA Received: 05/07/2019
• Supplement Dates Manufacturer Received: 06/12/2019
• Supplement Dates FDA Received: 06/24/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/22/2018
• 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
• Patient Outcome(s): Hospitalization; Required Intervention