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

Model Number	1688TC/40
Medical Device Problem Codes	Fracture (1260); High impedance (1291)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	07/13/2019
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 presented via remote transmission.The patient's atrial lead exhibited high impedance.Lead fracture was suspected.On (b)(6) 2019, the patient was brought into clinic and testing revealed high impedance.Lead replacement was discussed, but not performed.The patient was stable.
Additional Manufacturer Narrative
A partial lead with the distal portion measuring 43.0 cm was returned for analysis.External insulation abrasion was noted at 4.0 - 4.2 cm from distal tip consistent with friction to another device or feature of the patient anatomy.In addition, a fracture of all five filars of the inner coil was noted at 26.0 cm from distal tip.This fracture is consistent with the observation from the field of high lead impedance.
Event or Problem Description
New information states that the lead was explanted.

• 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: 8855595
• Report Number: 2017865-2019-11786
• Device Sequence Number: 11238740
• Product Code: NVN
• UDI-Device Identifier: 05414734504812
• UDI-Public: 05414734504812
• 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: 2014
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/23/2020

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: 08/31/2016
• Device Model Number: 1688TC/40
• Device Catalogue Number: 1688TC-40
• Device Lot Number: 4188820
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/16/2020
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 07/18/2019
• Supplement Date Received by Manufacturer: 01/16/2020; 02/20/2020
• Initial Report FDA Received Date: 08/02/2019
• Supplement Report FDA Received Date: 02/05/2020; 02/23/2020
• 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