BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORE RECHARGEABEL NEUROSTIMULATOR

    MDR report key: 1851183 · Received September 30, 2010

    Report

    Report Number
    3004209178-2010-07451
    Event Type
    Injury
    Date Received
    September 30, 2010
    Date of Event
    January 1, 2010
    Report Date
    September 2, 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
    MN, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4)

    Description of Event or Problem · 1

    IT WAS REPORTED THERE WERE COUPLING ISSUES DURING RECHARGING. AN IMPLANTABLE NEURO STIMULATOR (INS) OVERDISCHARGE WAS SUSPECTED. THE PATIENT HAD NOT CHARGED FOR A COUPLE OF MONTHS. COMPANY REPRESENTATIVE INITIATED PHYSICIAN MODE RECHARGE (PMR) WITH PATIENT. IT WAS FURTHER REPORTED THE PATIENT WAS IMPLANTED WITH A NEW IMPLANTABLE PULSE GENERATOR (IPG) AND HAD ORIGINAL 1X8 LEAD REVISED. THE EXPLANTED IPG WAS WORKING, BUT NOT HOLDING A CHARGE VERY LONG. THE PHYSICIAN MADE THE DECISION TO REPLACE THE UNIT. THE PATIENT WAS DOING WELL. ADDITIONAL INFORMATION WILL BE PROVIDED WHEN IT BECOMES AVAILABLE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 38 YR Required Intervention EXPLANTED:| IMPLANTED:| EXPLANTED:| IMPLANTED:| PROGRAMMER: MODEL 37742, LOT# NJD046205N| EXPLANTED:| ACCESSORY: MODEL 37752, LOT# NKA028769N| IMPLANTED:| LEAD: MODEL 3777, LOT# V022719034