MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC.(CRM-SYLMAR) OPTISURE ACTIVE FIXATION, DF-4 CONNECTOR; DEFIBRILLATION LEAD

Model Number	LDA220Q/52
Medical Device Problem Codes	Over-Sensing (1438); Retraction Problem (1536); Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	08/29/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Based on the information available at this time, the specific complaint file covered by this investigation does not warrant capa escalation individually.If new information is received, the need for corrective action will be reassessed.Device complaints will be monitored through tracking and trending and escalated to capa when appropriate.
Event or Problem Description
It was reported that the asymptomatic patient presented remotely via merlin.Net transmission.Review of the transmission noted oversensing on the right ventricular lead.The patient presented for a chest x-ray.The lead had dislodged.The patient presented to the hospital for lead revision procedure on (b)(6) 2018.Upon repositioning the lead, the helix would not extend.The lead was explanted and replaced.The patient was discharged from the hospital the next day.The patient had no symptoms during or after the procedure.
Additional Manufacturer Narrative
A complete lead was returned in one piece.The damage found was sustained during the surgical procedure.The lead was otherwise normal.

• Brand Name: OPTISURE ACTIVE FIXATION, DF-4 CONNECTOR
• Common Device Name: DEFIBRILLATION LEAD
• Manufacturer (Section D): ST. JUDE MEDICAL, INC.(CRM-SYLMAR); 15900 valley view court; sylmar CA 91342
• MDR Report Key: 7847170
• Report Number: 2017865-2018-13318
• Device Sequence Number: 11051728
• Product Code: NVY
• UDI-Device Identifier: 05414734507349
• UDI-Public: 05414734507349
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: P950022
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/02/2018

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: 01/31/2019
• Device Model Number: LDA220Q/52
• Device Lot Number: S000056035
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/20/2018
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 08/30/2018
• Supplement Date Received by Manufacturer: 10/17/2018
• Initial Report FDA Received Date: 09/05/2018
• Supplement Report FDA Received Date: 11/02/2018
• 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: Hospitalization; Required Intervention
• Patient Age: 58 YR