BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORE PRIME

    MDR report key: 2201778 · Received August 5, 2011

    Report

    Report Number
    3004209178-2011-06098
    Event Type
    Injury
    Date Received
    August 5, 2011
    Date of Event
    May 1, 2011
    Report Date
    July 14, 2011
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO., JUNCOS
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD AN INFECTION IN HIS HIP, POSSIBLY CELLULITIS. ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE INFECTION DEVELOPED APPROXIMATELY 8 WEEKS AFTER THE IMPLANTATION. THE BATTERY POCKET WAS DRAINING AND DID NOT CLOSE, DESPITE 2 WEEKS OF ANTIBIOTIC THERAPY. THE ENTIRE SYSTEM WAS EXPLANTED ON (B)(6) 2011. IT WAS REPORTED THAT THE MIDLINE INCISION WAS CLOSED WITHOUT DIFFICULTY BUT THE BATTERY POCKET REQUIRED PACKING AND WOULD REQUIRE SECONDARY CLOSURE. ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT WAS NO AVAILABLE AS OF THE DATE OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RESTORE PRIME LGW MEDTRONIC PUERTO RICO OPERATIONS CO., JUNCOS 37701 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Required Intervention IMPLANTED:| EXPLANTED:| LEAD: MODEL 3888, LOT# V650832| EXPLANTED:| EXPLANTED:| IMPLANTED:| EXTENSION: MODEL 37082, LOT# NKB009623V| EXPLANTED:| LEAD: MODEL 3888, LOT# V651569| EXPLANTED:| IMPLANTED:| LEAD: MODEL 3888, LOT# V650832| LEAD: MODEL 3888, LOT# V650832| IMPLANTED:| EXPLANTED:| EXTENSION: MODEL 37082, LOT# NKB009622V| IMPLANTED:| IMPLANTED: