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

Model Number	LDA220/65
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Unspecified Infection (1930)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
This product is registered as a combination product.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.The results/method and conclusion codes along with investigation results will be provided in the final report.
Event or Problem Description
Related manufacturer report number: 2017865-2020-09153.Related manufacturer report number: 2017865-2020-09154.It was reported that the patient experienced a significant swelling at the device pocket site and the incision site was warm and reddened.Upon opening the pocket for evacuation of hematoma and exploration of the pocket, cloudy fluid was noted inside and initial lab cultures revealed white blood cells.The system was removed.The patient was in stable condition.

• Brand Name: OPTISURE 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: 10271885
• Report Number: 2017865-2020-09155
• Device Sequence Number: 3495691
• Product Code: NVY
• UDI-Device Identifier: 05414734507202
• UDI-Public: 05414734507202
• Combination Product (Y/N): N
• Initial Reporter State: IA
• Initial Reporter Country: US
• PMA/510(K) Number: P950022
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 07/14/2020

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 01/31/2022
• Device Model Number: LDA220/65
• Device Catalogue Number: LDA220-65
• Device Lot Number: S000068162
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/25/2020
• Initial Report FDA Received Date: 07/14/2020
• 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: FORTIFY ASSURA DR ICD, US; TENDRIL STS
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 48 YR