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

Model Number 1458QL/75

Device Problem Device Dislodged or Dislocated (2923)

Patient Problems Twiddlers Syndrome (2114); Heart Failure (2206)

Event Date 06/17/2019

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's reference number: 2938836-2019-05153, 2938836-2019-05154, 2938836-2019-05160.It was reported that the patient presented in clinic because of heart failure.It was noted that extreme twiddler's syndrome caused the leads to be pulled back from the device.The rv and lv leads were explanted, but the ra was capped on (b)(6) 2019 because the lead was unable to be explanted.When attempting to re-implant the device, r wave amplitudes had differed significantly from previous measurements and loss of rv capture was observed.After multiple attempts to clean the header, the device was also explanted and replaced.The patient was stable.

• Brand Name: QUARTET
• Type of Device: PERMANENT PACEMAKER ELECTRODE
• 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: 8766011
• MDR Text Key: 150241590
• Report Number: 2938836-2019-05156
• Device Sequence Number: 1
• Product Code: NIK
• UDI-Device Identifier: 05414734510202
• UDI-Public: 05414734510202
• 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: 07/07/2019

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: 03/31/2020
• Device Model Number: 1458QL/75
• Device Catalogue Number: 1458QL/75
• Device Lot Number: A000038932
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 06/17/2019
• Initial Date FDA Received: 07/07/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/13/2017
• 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