BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORE PRIME ADVANCED

    MDR report key: 2210313 · Received August 9, 2011

    Report

    Report Number
    3004209178-2011-06203
    Event Type
    Injury
    Date Received
    August 9, 2011
    Date of Event
    July 11, 2011
    Report Date
    July 11, 2011
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO., JUNCOS
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WAS IN A GREAT DEAL OF PAIN ON (B)(6) 2011, AND THE PATIENT PRESENTED WITH WHAT LOOKED LIKE AN INFECTION AT THE POCKET SITE. THERE WAS SWELLING AT ONE CORNER OF THE POCKET SITE, AND REDNESS SPREADING OUT FROM ALL SIDES OF THE POCKET SITE. THERE WAS NO SKIN EROSION, BUT IT LOOKED LIKE A POSSIBILITY THAT IT COULD HAPPEN. THE HEALTH CARE PROVIDER PRESCRIBED ANTIBIOTICS. ON (B)(6) 2011, THE INTERNAL PULSE GENERATOR HAD ERODED THROUGH THE SKIN BY 3 OR 4 MM, AND THE FULL SYSTEM WAS SURGICALLY REMOVED. THE PATIENT WAS RECOVERING FROM THE EXPLANT WITHOUT SEQUELA. THE HCP BELIEVED THAT THE STIMULATOR WAS INFECTED DUE TO LACK OF SKIN INTEGRITY DUE TO THE PATIENT'S DIABETES. THE SYSTEM WAS DISPOSED OF AND WILL NOT BE RETURNED TO MEDTRONIC DUE TO THE PATIENT'S (B)(6). THERE WERE NO PLANS TO IMPLANT ANOTHER SYSTEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RESTORE PRIME ADVANCED LGW MDT PUERTO RICO OPERATIONS CO., JUNCOS 37702 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Required Intervention LEAD: MODEL 39565-30, LOT # N194374003| EXPLANTED:| IMPLANTED:| IMPLANTED:| EXTENSION: MODEL 37081, LOT # NJB057098V| EXPLANTED:| EXTENSION: MODEL 37081, LOT # NJB057600V| EXPLANTED:| PROGRAMMER: MODEL 37743, LOT # NKE155281N| IMPLANTED: