BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EXTERNAL PATIENT RECHARGER SYSTEM

    MDR report key: 1002341 · Received February 22, 2008

    Report

    Report Number
    2182207-2008-00889
    Event Type
    Injury
    Date Received
    February 22, 2008
    Date of Event
    January 1, 2007
    Report Date
    January 25, 2008
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    THE PT REPORTED THAT SHE HAD EXPERIENCED A WARM, BURNING SENSATION AT THE POCKET THAT ONLY OCCURRED DURING RECHARGING. SHE HAD BEEN BURNT DURING RECHARGING; THE HCP HAD INDICATED SHE DISPLAYED SIGNS OF A BURN. THE AREA WAS RED AND PURPLE AND HAD LOOKED BRUISED "SIMILAR TO A HICKY". THE SYMPTOMS HAD STARTED AFTER REPLACEMENT WITH A RECHARGEABLE SYSTEM IN 2007; THE AFFECTED AREA HAD MATCHED THE SIZE AND ROUND SHAPE OF THE RECHARGED PRODUCT. SHE HAD RECHARGED TWICE SINCE THEN, BOTH TIMES SHE HAD EXPERIENCED SYMPTOMS AT THE INS IMPLANT SITE. THE SECOND TIME SHE RECHARGED, THE AREA OF HER SKIN THAT WAS AFFECTED "WASN'T AS BIG AS THE FIRST TIME RECHARGING." AT FOLLOW-UP, THE PT HAD BEEN CHECKED FOR SIGNS OF INFECTION (DATE WAS NOT PROVIDED); THE PT "HAD BEEN TOLD THERE IS INFLAMMATION DUE TO THE WAY THE INS IS POSITIONED, BUT NOT ANYTHING ELSE." THE PT RECHARGED WITH A RIB WRAP FOR USE "BECAUSE OF THE WAY THE HCP THINKS THE INS IS POSITIONED IN THE BODY." THE PT WAS ADVISED TO PLACE A THERMOMETER BETWEEN THE RECHARGER AND HER SKIN WHEN RECHARGING TO SEE IF THE TEMPERATURE REACHED IS HIGHER THAN THE SAFETY FEATURE, WHICH SHUTS DOWN THE RECHARGER AT TEMPERATURES OF 101 DEGREES F. THE PT'S STATUS HAD BEEN UNDETERMINED; SHE WAS REDIRECTED TO REPORT SYMPTOMS TO THE PHYSICIAN. SHE ANTICIPATED FOLLOW-UP WITH THE HCP IN THE 2008, TIMEFRAME. ADD'L INFO HAS BEEN REQUESTED FROM THE PHYSICIAN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EXTERNAL PATIENT RECHARGER SYSTEM LGW MEDTRONIC NEUROMODULATION 37752 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 YR Required Intervention IMPLANTABLE NEURO STIMULATOR MODEL 37713| IMPLANTED| IMPLANTED| LEAD MODEL 3887 LOT# J0108061V| IMPLANTED| LEAD MODEL 3887 LOT# J0437035V| LEAD MODEL 3887 LOT# J0107905V| EXTENSION MODEL 37082 LOT# NKB002963N| LOT# NJK707126H| EXPLANTED| EXPLANTED| IMPLANTED| EXPLANTED| IMPLANTED| EXPLANTED| EXPLANTED| EXTENSION MODEL 37082 LOT# NKB003016N| IMPLANTED| EXPLANTED