MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC.(CRM-SYLMAR) DURATA STS OPTIM ACTIVE FIXATION; DEFIBRILLATION LEAD

Model Number	7122/75
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	07/16/2019
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 (b)(6) 2019 for a routine procedure for a generator change.During the procedure an insulation breach was observed on the lead.The patient remained in hospital and the lead was extracted (b)(6) 2019.The patient was stable before, during and after the procedure and was discharged.
Additional Manufacturer Narrative
The reported event of insulation abrasion was confirmed.As received, a complete lead was returned in two pieces.Connector portion (a) measured 12.9cm while distal portion (b) measured 62.3cm/60.0cm (ptfe liner, cables and inner coil/lead body).Visual inspection of the lead found an external insulation abrasion (50.0 cm to 50.3cm from the distal tip) breaching the right ventricular cable lumen proximal to suture sleeve tie impression.The ethylene tetrafluoroethylene (etfe) cable coating was not abraded in this location.The cause of the external insulation abrasion was consistent with friction to the device can.The right ventricular shock coil was shifted distally consistent with procedural damage.Further analysis found two internal insulation abrasions breaching the right ventricular (6.0 cm to 6.8 cm from the distal tip) and ring electrode (6.4cm to 6.8cm from the distal tip) cable lumens underneath the right ventricular shock coil.One right ventricular etfe cable coating was abraded while the ring electrode cables were not abraded in these locations.Explant date should have been (b)(6) 2019 not (b)(6) 2019.

• Brand Name: DURATA STS OPTIM ACTIVE FIXATION
• Common Device Name: DEFIBRILLATION LEAD
• Manufacturer (Section D): ST. JUDE MEDICAL, INC.(CRM-SYLMAR); 15900 valley view court; sylmar CA 91342
• MDR Report Key: 8842727
• Report Number: 2017865-2019-11600
• Device Sequence Number: 1618042
• Product Code: LWS
• UDI-Device Identifier: 05414734502160
• UDI-Public: 05414734502160
• Combination Product (Y/N): N
• Initial Reporter Country: NZ
• PMA/510(K) Number: P950022
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2010
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/12/2019

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 Model Number: 7122/75
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/07/2019
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 07/18/2019
• Supplement Date Received by Manufacturer: 09/03/2019
• Initial Report FDA Received Date: 07/30/2019
• Supplement Report FDA Received Date: 09/12/2019
• 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: Hospitalization; Required Intervention