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

Model Number	1688TC/40
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Death (1802)
Date of Event	10/28/2018
Type of Reportable Event	Death
Event or Problem Description
It was reported that the patient has deceased.There is no known allegation from a health care professional that suggests that the death was device related.The cause of death was brain death, cardiac arrest, and valvular heart disease.No additional information was reported.
Additional Manufacturer Narrative
A partial lead with the connector pin measuring 5.9cm was returned for analysis.The damage found was sustained during the surgical procedure.The portion of the lead that was returned was otherwise normal.Without return of the entire lead, a complete analysis could not be performed.

• Brand Name: TENDRIL SDX LEAD
• Common Device Name: PERMANENT PACEMAKER ELECTRODE
• Manufacturer (Section D): ST. JUDE MEDICAL, INC.(CRM-SYLMAR); 15900 valley view court; sylmar CA 91342
• MDR Report Key: 8108066
• Report Number: 2017865-2018-17800
• Device Sequence Number: 2118775
• Product Code: NVN
• UDI-Device Identifier: 05414734504812
• UDI-Public: 05414734504812
• 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: 2010
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/10/2018

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 06/30/2013
• Device Model Number: 1688TC/40
• Device Lot Number: 3155818
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/13/2018
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 11/13/2018
• Supplement Date Received by Manufacturer: 12/06/2018
• Initial Report FDA Received Date: 11/27/2018
• Supplement Report FDA Received Date: 12/10/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 1688TC/46, (B)(4); PM2210, (B)(4)
• Outcome Attributed to Adverse Event: Death
• Patient Age: 48 YR