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

Model Number	1888TC/46
Medical Device Problem Codes	Signal Artifact/Noise (1036); Break (1069); Fracture (1260)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	09/27/2016
Type of Reportable Event	Malfunction
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 noted that the patient presented for follow-up on (b)(6) 2009, the patient had experienced a sensation of palpitations with exertion but at the time, diaphragmatic stimulation could not be elicited.The device was reprogrammed and the symptoms seemed to have been resolved.It was reported that the patient presented for lead revision and device change out procedure on (b)(6) 2016.The left ventricular lead exhibited diaphragmatic stimulation despite having a history of reprogramming and the right atrial lead exhibited noise.Both leads were explanted and replaced successfully.
Additional Manufacturer Narrative
Correction: the previously reported describe event or problem in the initial report was incorrect.The describe event or problem in this report is correct and should supersede the previously reported.(b)(4).
Event or Problem Description
It was noted that the patient presented for follow-up on (b)(6) 2009, the patient had experienced a sensation of palpitations with exertion but at the time, diaphragmatic stimulation could not be elicited.The device was reprogrammed and the symptoms seemed to have been resolved.It was reported that the patient presented for lead revision and device change out procedure on (b)(6) 2016.The left ventricular lead exhibited diaphragmatic stimulation despite having a history of reprogramming.It was also noted that right atrial lead was fractured, had insulation damage, and exhibited noise.Both leads were explanted and replaced successfully.

• Brand Name: TENDRIL ST
• 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: 7644187
• Report Number: 2017865-2018-09398
• Device Sequence Number: 2324329
• Product Code: NVN
• UDI-Device Identifier: 05414734501958
• UDI-Public: 05414734501958
• Combination Product (Y/N): N
• Initial Reporter State: SC
• Initial Reporter Country: US
• PMA/510(K) Number: P960013
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2009
• Device Explanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/09/2018

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 03/31/2012
• Device Model Number: 1888TC/46
• Device Lot Number: 2778500
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 05/29/2018
• Supplement Date Received by Manufacturer: 09/27/2018
• Initial Report FDA Received Date: 06/27/2018
• Supplement Report FDA Received Date: 10/09/2018
• 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
• Patient Age: 66 YR