BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORE RECHARGEABLE NEUROSTIMULATOR

    MDR report key: 1800586 · Received August 12, 2010

    Report

    Report Number
    3004209178-2010-06070
    Event Type
    Injury
    Date Received
    August 12, 2010
    Date of Event
    June 1, 2010
    Report Date
    July 15, 2010
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO., JUNCOS
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT EXPERIENCED A PERSISTENT LEFT OCCIPITAL HEADACHE AND LEFT CERVICAL PAIN. AN X-RAY WAS PERFORMED (B)(6) 2010. IT WAS NOTED THAT THE LEFT CERVICAL NEUROELECTRODE HAD MIGRATED. THE NEUROELECTRODE WAS REPOSITIONED TO A MORE MIDLINE POSITION. THE PATIENT RESOLVED WITHOUT SEQUELAE. NO FURTHER DETAILS WERE PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RESTORE RECHARGEABLE NEUROSTIMULATOR LGW MDT PUERTO RICO OPERATIONS CO., JUNCOS 37711 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Required Intervention IMPLANTED:| LEAD: MODEL 3487A, LOT# J0111022V| LEAD: MODEL 3986A, LOT# N101282| EXPLANTED:| EXPLANTED:| EXTENSION: MODEL 37081, LOT# NJB006141V| IMPLANTED:| LEAD: MODEL 3888, LOT# J0104242V| LEAD: MODEL 3487A, LOT# V037174| EXTENSION: MODEL 37082, LOT# NKB002607N| EXPLANTED:| IMPLANTED:| EXPLANTED:| IMPLANTED:| EXPLANTED:| IMPLANTED:| IMPLANTED:| EXPLANTED:| IMPLANTED:| EXTENSION: MODEL 37082, LOT# NKB009339N| EXPLANTED: