MAUDE Adverse Event Report: ABBOTT QUARTET; PERMANENT PACEMAKER ELECTRODE

Model Number 1458Q/86

Device Problems Signal Artifact/Noise (1036); Under-Sensing (1661); Device Dislodged or Dislocated (2923)

Patient Problem Twiddlers Syndrome (2114)

Event Date 09/06/2019

Event Type  Injury  

Manufacturer Narrative

The results, method, and conclusion codes along with investigation results will be provided in the final report.

Event Description

During a clinic follow-up, noise was observed on the left ventricular (lv) lead.Diagnostic imaging was performed and revealed lv lead dislodgement due to twiddler's syndrome.The lv lead was explanted and replaced to resolve the event.The patient was stable and will continue to be monitored.

Event Description

Additional information received that undersensing was noted on the left ventricular (lv) lead.

Manufacturer Narrative

As received, a complete lead was returned in one piece for analysis.The reported events of noise and under-sensing were not confirmed.Electrical testing did not reveal any indication of conductor fractures or internal shorts.Visual inspection and x-ray examination of the lead did not reveal any anomalies.The s-curve hump height was measured within product specification.

• Brand Name: QUARTET
• Type of Device: PERMANENT PACEMAKER ELECTRODE
• 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: 9099218
• MDR Text Key: 159393493
• Report Number: 2017865-2019-13913
• Device Sequence Number: 1
• Product Code: OJX
• UDI-Device Identifier: 05414734503198
• UDI-Public: 05414734503198
• 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,Followup
• Report Date: 10/30/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/20/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2022
• Device Model Number: 1458Q/86
• Device Lot Number: S000068542
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/25/2019
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/23/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/26/2019
• 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): Hospitalization; Required Intervention