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

Model Number	LDA220Q/52
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	08/03/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the right ventricular lead had pulled back significantly via review of x-ray.The svc coil was back in the subclavian, and it was believed the lead was caught up in the tricuspid annulus.The lead was tested day of procedure and measurements were normal.The lead was successfully removed by laser rv lead extraction and replaced with a new rv lead.The patient was stable before, during and after the procedure.
Additional Manufacturer Narrative
A partial lead with the connector pin measuring 42.8 cm 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: OPTISURE ACTIVE FIXATION, DF-4 CONNECTOR
• Common Device Name: DEFIBRILLATION LEAD
• Manufacturer (Section D): ST. JUDE MEDICAL, INC.(CRM-SUNNYVALE); 645 almanor avenue; sunnyvale CA 94085
• MDR Report Key: 7804971
• Report Number: 2938836-2018-09905
• Device Sequence Number: 13738970
• 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: 2016
• 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): 09/04/2018

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: 03/31/2017
• Device Model Number: LDA220Q/52
• Device Lot Number: S000017399
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/13/2018
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 08/03/2018
• Supplement Date Received by Manufacturer: 08/28/2018
• Initial Report FDA Received Date: 08/22/2018
• Supplement Report FDA Received Date: 09/04/2018
• 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