BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORE RECHARGABLE NEUROSTIMULATOR

    MDR report key: 1842096 · Received September 20, 2010

    Report

    Report Number
    3004209178-2010-07098
    Event Type
    Injury
    Date Received
    September 20, 2010
    Date of Event
    March 1, 2009
    Report Date
    September 2, 2010
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO., JUNCOS
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IN (B)(6) 2009, THE IMPLANTABLE NEUROSTIMULATOR (INS) WAS OVERDISCHARGED. IN (B)(6) 2010, AN OVERDISCHARGE WAS SUSPECTED; THE INS WAS NOT RESPONDING TO THE PHYSICIAN PROGRAMMER (IT IS UNCLEAR IF THE INS HAD BEEN BROUGHT OUT OF THE PRIOR OVERDISCHARGE). AT THAT TIME, THE PT WAS ALSO BEING ASSESSED FOR A SUSPECTED INFECTION AT THE INS POCKET. IN (B)(6) 2010, IT WAS REPORTED THAT THE PT HAD GOTTEN BETTER RELIEF WITH HIS FIRST TWO INSS. THE PT DECIDED THAT HE DIDN'T WANT TO GO THROUGH ANY MORE SURGERIES, SO HE WAS TAKING ORAL PAIN PRESCRIPTIONS. ONE DAY, THE PT HAD SOME HIGH BACK PAIN, SO HE LAID ON A HEATING PAD. THE HEATING PAD BURNED A SMALL HOLE IN THE SKIN AT THE POINT OF THE INS AND IT GOT INFECTED. THE PT WAS HOSPITALIZED AND THE PHYSICIAN "DID AN EXCELLENT JOB OF REMOVING THE STIMULATOR, WIRES, AND INFECTION".

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Required Intervention LOT# NFE403448H| IMPLANTABLE NEURO STIMULATOR: MODEL 7427V,| IMPLANTED:| IMPLANTED:| EXPLANTED:| IMPLANTED:| IMPLANTED:| LEAD: MODEL 3487A, LOT# J0337686V| EXPLANTED:| LEAD: MODEL 3487A, LOT# J0337686V| PROGRAMMER: MODEL 37742, LOT# NJD016719N| EXPLANTED:| IMPLANTED:| EXTENSION: MODEL 37083, LOT# NKC002918N| EXPLANTED:| IMPLANTED:| IMPLANTED:| LEAD: MODEL 3487A, LOT# J0436930V| EXPLANTED:| PROGRAMMER: MODEL 7435, LOT# NFT032577P| EXPLANTED:| IMPLANTED:| EXTENSION: MODEL 7489, LOT# NHU024768V| ACCESSORY: MODEL RECHARGER, LOT# UNK I| EXPLANTED:| EXTENSION: MODEL 7489, LOT# NHU020860V| EXTENSION: MODEL 37083, LOT# NKC002903N| IMPLANTED:| EXPLANTED:| IMPLANTED:| EXPLANTED:| EXPLANTED:| LOT# NFE405061H| IMPLANTABLE NEURO STIMULATOR: MODEL 7427V,