BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK SPINAL CORD STIMULATOR

    MDR report key: 1901956 · Received November 12, 2010

    Report

    Report Number
    3007566237-2010-09416
    Event Type
    Injury
    Date Received
    November 12, 2010
    Date of Event
    June 17, 2010
    Report Date
    October 28, 2010
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE IMPLANTABLE NEUROSTIMULATOR (INS) WOULD NOT RECHARGE, AND THE PATIENT RECEIVED INADEQUATE PAIN RELIEF AND PAIN AT THE GLUTEAL SITE WHERE THE INS WAS LOCATED. THE DEVICE SYSTEM WAS EXPLANTED. 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 UNK SPINAL CORD STIMULATOR LGW MEDTRONIC NEUROMODULATION IPGNEURO NA

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Required Intervention