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

Model Number	1999/40
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	05/26/2020
Type of Reportable Event	Malfunction
Additional 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 or Problem Description
It was reported that during a device changing procedure, externalized conductor was observed on the atrial lead.Atrial lead insulation was pulled back to the suture sleeve area, and the conductor coil of the lead was exposed.The lead was repaired with medical adhesive.The patient was stable and being monitored.

• Brand Name: OPTISENSE LEAD
• Common Device Name: PERMANENT PACEMAKER ELECTRODE
• Manufacturer (Section D): ST. JUDE MEDICAL, INC.(CRM-SUNNYVALE); 645 almanor avenue; sunnyvale CA 94085
• MDR Report Key: 10143480
• Report Number: 2938836-2020-06785
• Device Sequence Number: 16887566
• Product Code: NVN
• UDI-Device Identifier: 05414734502467
• UDI-Public: 05414734502467
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: P960013
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2011
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/22/2020

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: 09/30/2012
• Device Model Number: 1999/40
• Device Catalogue Number: 1999-40
• Device Lot Number: 2872289
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 05/26/2020
• Supplement Date Received by Manufacturer: 06/22/2020
• Initial Report FDA Received Date: 06/11/2020
• Supplement Report FDA Received Date: 06/22/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1