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

Model Number 1458Q/86

Device Problems Difficult to Insert (1316); Separation Failure (2547); Device Dislodged or Dislocated (2923)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/03/2020

Event Type  malfunction  

Manufacturer Narrative

This product is registered as a combination product.The results/method and conclusion codes along with investigation results will be provided in the final report.

Event Description

It was reported that when the patient presented for implant procedure, the left ventricular lead dislodged after implanted at suitable position.During the second implant attempt, the guidewire was difficult to insert into the lead and could not be separated back after insertion.The lead was not used and replaced.The patient was stable.

Manufacturer Narrative

The reported event of guidewire difficult to insert/remove was confirmed.A complete lead was returned for analysis with a broken guidewire inserted in the inner coil lumen.The cause of the reported event of guidewire insertion and removal difficulty was due to guidewire being bent/kinked, inner coil offset and ptfe coating of the guidewire stripped.All damages found were sustained during the surgical procedure.The lead was otherwise normal.

• 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: 10553066
• MDR Text Key: 207510195
• Report Number: 2938836-2020-08345
• 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: 10/23/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2023
• Device Model Number: 1458Q/86
• Device Catalogue Number: 1458Q-86
• Device Lot Number: A000093441
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/29/2020
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 09/03/2020
• Initial Date FDA Received: 09/18/2020
• Supplement Dates Manufacturer Received: 10/16/2020
• Supplement Dates FDA Received: 10/23/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 80 YR
• Patient Weight: 50