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

Model Number 1458Q/92

Device Problems Failure to Capture (1081); Loose or Intermittent Connection (1371); Pocket Stimulation (1463); Failure to Disconnect (2541); Device Dislodged or Dislocated (2923)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 07/22/2019

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

It was reported that when patient presented to clinic as a new patient, device interrogation revealed loss of capture on lv lead along with pocket stimulation from pacing.X-ray revealed lv lead dislodgement.Lv pacing was programmed off.Lead revision was planned.The patient was stable.

Event Description

New information received notes that the when patient presented for lead revision, the lead was not able to be re-inserted as guidewire could not be removed from the distal end of lead.It was further noted that the lead was not attached to a suture sleeve in the pocket and that the suture sleeve was still tied down by itself.The old left ventricular(lv) lead was explanted and replaced.The patient was stable.

Manufacturer Narrative

The damage found was 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
• 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: 8867817
• MDR Text Key: 153525757
• Report Number: 2938836-2019-06714
• Device Sequence Number: 1
• Product Code: OJX
• UDI-Device Identifier: 05414734503358
• UDI-Public: 05414734503358
• 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: Nurse
• Type of Report: Initial,Followup,Followup
• Report Date: 11/12/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/06/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2022
• Device Model Number: 1458Q/92
• Device Lot Number: A000076714
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/24/2019
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/12/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/18/2019
• 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): Required Intervention