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

Model Number	1458QL/92
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	12/28/2019
Type of Reportable Event	Serious Injury
Additional 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 or Problem Description
It was reported that the patient was seen for a threshold test and the lv lead was found to be pulled via chest x-ray into the pocket.Prior to this event, there were episodes of a-fib with rvr where the patient got shocked several times.The device was reprogrammed for rv only given the lv lead being dislodged.Device and lead remains implanted.Related manufacturer reference number: 2938836-2020-00452.
Event or Problem Description
New information notes that on (b)(6) 2020, the lead was explanted and replaced.The device remains implanted and the patient is stable.

• Brand Name: QUARTET
• Common Device Name: PERMANENT PACEMAKER ELECTRODE
• Manufacturer (Section D): ST. JUDE MEDICAL, INC.(CRM-SUNNYVALE); 645 almanor avenue; sunnyvale CA 94085
• MDR Report Key: 9599391
• Report Number: 2938836-2020-00451
• Device Sequence Number: 11583779
• Product Code: NIK
• UDI-Device Identifier: 05414734510226
• UDI-Public: 05414734510226
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: P030054
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/05/2020

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
• Operator of Device: Health Professional
• Device Expiration Date: 08/31/2020
• Device Model Number: 1458QL/92
• Device Catalogue Number: 1458QL/92
• Device Lot Number: A000045218
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 12/28/2019
• Supplement Date Received by Manufacturer: 03/17/2020
• Initial Report FDA Received Date: 01/16/2020
• Supplement Report FDA Received Date: 04/05/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention