BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORE RECHARGEABLE NEUROSTIMULATOR

    MDR report key: 1953504 · Received January 5, 2011

    Report

    Report Number
    3007566237-2011-00073
    Event Type
    Injury
    Date Received
    January 5, 2011
    Date of Event
    March 1, 2010
    Report Date
    December 6, 2010
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WV, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE ANALYSIS WAS NOT COMPLETE AS OF THE DATE OF THIS REPORT. A FOLLOW UP REPORT WILL BE SUBMITTED WHEN DEVICE ANALYSIS IS COMPLETE.

    Description of Event or Problem · 1

    IT WAS REPORTED THE PT WAS GETTING NO STIMULATION IN THE RIGHT ARM. THE PT WAS HAVING ABDOMINAL PAIN, WHEN THE DEVICE WAS ON OR OFF, THAT TRAVELED UP TO THE SPINE, AND COULD FEEL STIMULATION WHEN TURNING HER NECK TO THE RIGHT. IT WAS ALSO REPORTED THE DEVICE WOULD JERK HER, CAUSING AN INABILITY TO CONTROL HER MOVEMENTS. ADDITIONAL SYMPTOMS INCLUDED TENDERNESS AT THE INS SITE WHICH CAUSED PAIN DURING RECHARGING. IT WAS REPORTED, FOR THREE DAYS THE DEVICE DIDN'T WORK BECAUSE THE BATTERY WAS DEPLETED AND IT WAS NOT POSSIBLE TO GET IT GOING AGAIN. A FEW DAYS LATER THE PT WAS SUDDENLY ABLE TO RECHARGE SUCCESSFULLY. THE AMPLITUDE OF THE DEVICE WAS SET AT 3.0 AS TURNING THE DEVICE UP HIGHER CAUSED THE PT'S BODY TO "CRIMPLE". ADDITIONAL INFO INDICATED THE PT'S PHYSICIAN WANTED TO REMOVE THE INS, HOWEVER, THE PT WANTED THE DEVICE RELOCATED TO THE OTHER SIDE OF THE BODY. THE PT EXPERIENCED ACUTE PAIN AT THE SITE, AND PAIN FROM HER RSD. THE PT EXPERIENCED THE PAIN EVEN WHEN THE DEVICE WAS OFF. THE DEVICE REMAINED OFF. THE AREA WAS PINK IN COLOR AND COULD FEEL COLD, HOT, OR A BURNING SENSATION. THE PT HAD BEEN TO THE ER DUE TO THE PAIN. ADDITIONAL INFO RECEIVED FROM THE HCP INDICATED THE EVENT WAS ATTRIBUTED TO THE LEAD. THE PT WAS TO HAVE THE DEVICE REMOVED. SYMPTOMS REPORTED, INCLUDED LACK OF EFFECT, OVERSTIMULATION AND NO STIMULATION. THE HCP REPORTED THE SYMPTOMS AS NON-SERIOUS. THE DEVICE SYSTEM WAS REMOVED FROM THE RIGHT ABDOMEN AND RETURNED TO THE MANUFACTURER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RESTORE RECHARGEABLE NEUROSTIMULATOR LGW MEDTRONIC NEUROMODULATION 37711 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Required Intervention EXTENSION: MODEL 7495LZ, LOT# NHK020533V| IMPLANTED:| STIM ACCESSORY: MODEL PLUG/IPG, LOT# UNK| EXPLANTED:| EXPLANTED:| IMPLANTED:| EXPLANTED:| LEAD: MODEL 3892, LOT# J0322188V| IMPLANTED:| PROGRAMMER: MODEL 7435, LOT# NFT013713P