BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORE ULTRA

    MDR report key: 1130964 · Received August 21, 2008

    Report

    Report Number
    3004209178-2008-05123
    Event Type
    Injury
    Date Received
    August 21, 2008
    Date of Event
    July 1, 2008
    Report Date
    July 23, 2008
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE PATIENT HAD A REVISION BECAUSE THE IMPLANTABLE NEUROSTIMULATOR (INS) SLIPPED IN THE POCKET. DURING THE REVISION, THE HEALTH CARE PROFESSIONAL (HCP) PUT A MESH DACRON POUCH AROUND THE INS. THE PATIENT DEVELOPED REDNESS AT THE INCISION SITE. THE HCP FELT THE PATIENT MAY BE ALLERGIC TO THE DACRON POUCH; THE HCP DID NOT THINK THERE WAS AN INFECTION. ADDITIONAL INFORMATION HAS BEEN REQUESTED, A FOLLOW-UP REPORT WILL BE SENT IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RESTORE ULTRA LGW MEDTRONIC PUERTO RICO OPERATIONS CO. 37712 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention EXTENSION MODEL 37081 LOT# NJB036761V| EXPLANTED:| IMPLANTED:| EXPLANTED:| PROGRAMMER MODEL 37743 LOT# NKE104578N| LEAD MODEL 39565 LOT# N153624003| IMPLANTED,| ACCESSORY MODEL 37752 LOT# NKA114117N| EXTENSION MODEL 37081 LOT# NJB036762V| IMPLANTED:| EXPLANTED: