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

Model Number	LDP220Q/65
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Wound Dehiscence (1154); Hematoma (1884)
Date of Event	11/12/2020
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.
Event or Problem Description
It was reported that a patient had a large hematoma following implant.At clinic follow up, the patient's wound was heeling better than what was previously thought.A pocket revision and wound debridement was done on (b)(6) 2020 to address this issue.The patient was stable.Related manufacturer reference number: 2017865-2020-19568.
Event or Problem Description
New information notes that a small area at the end of the pocket incision site has not healed post implant.The defibrillator and lead were extracted.Possible re-implant contralaterally to allow the skin to fully heal.It was unsure if the patient suffered an infection but was given antibiotics preemptively.The patient was stable.
Additional Manufacturer Narrative
Analysis was normal.No anomalies were found.

• Brand Name: OPTISURE PASSIVE 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: 10928919
• Report Number: 2017865-2020-19570
• Device Sequence Number: 2644730
• Product Code: NVY
• UDI-Device Identifier: 05414734507455
• UDI-Public: 05414734507455
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: P950022
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/17/2021

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: 04/30/2021
• Device Model Number: LDP220Q/65
• Device Catalogue Number: LDP220Q-65
• Device Lot Number: A000096075
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/12/2021
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 11/12/2020
• Supplement Date Received by Manufacturer: 04/01/2021; 04/26/2021
• Initial Report FDA Received Date: 12/01/2020
• Supplement Report FDA Received Date: 04/21/2021; 05/17/2021
• 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 VR ICD, US; FORTIFY ASSURA VR ICD, US
• Outcome Attributed to Adverse Event: Required Intervention