MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC.(CRM-SUNNYVALE) 5366, INTEGRITY DR, AB 20 73 559; IMPLANTABLE PACEMAKER PULSE GENERATOR

Model Number	5366
Medical Device Problem Code	Pacing Intermittently (1443)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The results/method and conclusion codes along with investigation results will be provided in the final report.
Event or Problem Description
It was reported that during the replacement procedure, the pacemaker rate dropped to 30 beats per minute and then intermittent loss of output was observed.The device was explanted and replaced.The patient condition was excellent.
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.

• Brand Name: 5366, INTEGRITY DR, AB 20 73 559
• Common Device Name: IMPLANTABLE PACEMAKER PULSE GENERATOR
• Manufacturer (Section D): ST. JUDE MEDICAL, INC.(CRM-SUNNYVALE); 645 almanor avenue; sunnyvale CA 94085
• MDR Report Key: 9453950
• Report Number: 2938836-2019-17176
• Device Sequence Number: 2158792
• Product Code: DXY
• UDI-Device Identifier: 05414734006866
• UDI-Public: 05414734006866
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: P880086
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2006
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/18/2020

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
• Operator of Device: Health Professional
• Device Expiration Date: 04/30/2007
• Device Model Number: 5366
• Device Catalogue Number: 5366
• Device Lot Number: 0002302065
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 11/22/2019
• Supplement Date Received by Manufacturer: 02/18/2020
• Initial Report FDA Received Date: 12/11/2019
• Supplement Report FDA Received Date: 02/18/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1