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

Model Number 1458Q/86

Device Problem Device Dislodged or Dislocated (2923)

Patient Problem Undesired Nerve Stimulation (1980)

Event Date 03/10/2020

Event Type  Injury  

Manufacturer Narrative

This product is registered as a combination product.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: 2017865-2020-10277.It was reported that the patient complaint of pain at the implantable cardioverter-defibrillator (icd) site since implant.Further investigation noted the left ventricular (lv) lead had dislodged the day after implant, and every vector tested had phrenic nerve stimulation.The dislodgement was confirmed on x-ray the day after implant.The lv lead was turned off due to lack of lv options for revision.The patient was brought into lab for pocket revision and lv lead explant.The lv lead was explanted with no complications.The physician elected to explant and replace the icd as well.The patient was stable and was discharged.

Manufacturer Narrative

Additional information: d10, h3, h6, h10 as received, a complete lead was returned in one piece.Electrical testing did not find any indication of conductor fractures or internal shorts.Visual inspection of the lead did not find any anomalies with the exception of procedural damage.The full measured s-curve hump height was within specification.

• Brand Name: QUARTET
• Type of Device: PERMANENT PACEMAKER ELECTRODE
• Manufacturer (Section D): ST. JUDE MEDICAL, INC.(CRM-SYLMAR); 15900 valley view court; sylmar CA 91342
• MDR Report Key: 10350224
• MDR Text Key: 201206347
• Report Number: 2017865-2020-10278
• 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,health
• Type of Report: Initial,Followup,Followup
• Report Date: 01/14/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/31/2020
• 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: 1458Q/86
• Device Catalogue Number: 1458Q-86
• Device Lot Number: A000084131
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/29/2020
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/13/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: QUADRA ASSURA MP ICD; QUADRA ASSURA MP ICD
• Patient Outcome(s): Required Intervention
• Patient Age: 68 YR