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 Codes	Retraction Problem (1536); Decreased Sensitivity (2534); High Capture Threshold (3266)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	06/09/2018
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 pacing capture threshold of right ventricular lead was doubled since implant and r-waves were diminishing.The cause of electrical issues was not determined.The patient was scheduled for lead revision procedure.During procedure, physician was unable to reposition the lead because helix could not be extended or retracted.The physician elected to leave the rv lead in place.Patient will be scheduled for another procedure.The patient was stable and asymptomatic throughout.
Event or Problem Description
New information received notes that the rv lead was explanted and replaced.
Event or Problem Description
New information received notes that the patient was stable during and post procedure.

• 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: 7655438
• Report Number: 2938836-2018-08347
• Device Sequence Number: 1512622
• Product Code: NVY
• UDI-Device Identifier: 05414734507349
• UDI-Public: 05414734507349
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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,Followup
• Report Date (Section B): 08/21/2018

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: 12/31/2018
• Device Model Number: LDA220Q/52
• Device Lot Number: S000054544
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 06/09/2018
• Supplement Date Received by Manufacturer: 07/17/2018; 08/17/2018
• Initial Report FDA Received Date: 07/02/2018
• Supplement Report FDA Received Date: 08/13/2018; 08/21/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 1458Q/75, (B)(4)
• Outcome Attributed to Adverse Event: Required Intervention