BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IMIMRESTORE ADVANCED RECHARGEABLE

    MDR report key: 2070157 · Received April 25, 2011

    Report

    Report Number
    3004209178-2011-03067
    Event Type
    Injury
    Date Received
    April 25, 2011
    Date of Event
    July 1, 2009
    Report Date
    April 6, 2011
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO., JUNCOS
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS INITIALLY REPORTED THAT THE INS WAS IMPLANTED IN THE PT'S BACK AND WHEN THEY SAT DOWN, IT CAUSED PAIN. ALSO REPORTED THAT THE DEVICE WAS STICKING OUT OF THE SKIN ON THEIR BACK. FOLLOWING IMPLANT, THE PT HAD AN INFECTION WHICH THEY TREATED WITH SALINE WATER AND BANDAGES. THE INFECTION RESOLVED. IN F/U REPORTING, THE HCP NOTED THAT THERE WAS MALPOSITION OF THE GENERATOR WHICH CAUSED THE EVENT. THERE WAS WOUND DEHISCENCE WITH EXPOSURE AND CONTAMINATION OF THE GENERATOR. THE DEVICE WAS EXPLANTED. THE WOUND REMAINED OPENED AND HEALED BY SECONDARY INTENTION WITHOUT SEQUELAE. THE STIMULATOR WAS REPLACED IN A BETTER LOCATION. PT OUTCOME WAS RECOVERED WITHOUT SEQUELAE. SEE MFR'S REPORT # 3004209178-2011-03069.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 IMIMRESTORE ADVANCED RECHARGEABLE LGW MDT PUERTO RICO OPERATIONS CO., JUNCOS 37713 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Hospitalization| R LEAD: MODEL 39565-30, LOT# N124476006| PROGRAMMER: MODEL 37742, LOT# NJD062459N| EXPLANTED:| IMPLANTED:| IMPLANTED:| IMPLANTED:| IMPLANTED:| EXPLANTED:| ACCESSORY: MODEL 37752, LOT# NKA033960N| IMPLANTED:| EXPLANTED:| EXTENSION: MODEL 37081, LOT# NJB044571V| EXPLANTED:| EXTENSION: MODEL 37081, LOT# NJB031043V| EXPLANTED: