BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE SENSOR

    MDR report key: 5545102 · Received April 4, 2016

    Report

    Report Number
    3004209178-2016-05984
    Event Type
    Malfunction
    Date Received
    April 4, 2016
    Date of Event
    March 6, 2016
    Report Date
    April 27, 2016
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 37761, SERIAL# (B)(4), PRODUCT TYPE: RECHARGER. A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    ANALYSIS OF THE DESKTOP CHARGER (B)(4) FOUND THE CONNECTOR PINS WERE BROKEN ON THE CABLE ASSEMBLY.

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    THE PATIENT REPORTED THAT THEY STOPPED USING THEIR IMPLANTABLE NEUROSTIMULATOR (INS) BECAUSE THEIR PAIN STARTED TO GO AWAY. THEIR KNEE PAIN HAD RECENTLY COME BACK BECAUSE THEY HAD BEEN USING THEIR KNEES MORE. WHEN THEY TRIED TO CHARGE THEIR RECHARGER THE SCREEN WAS STILL BLANK AFTER BEING PLUGGED IN FOR 24 HOURS. THE METAL PIECE ON THE DESKTOP CHARGER CAME APART AND THERE WAS A LOOSE CONNECTOR PIN ON THE DESKTOP CHARGER. THE DESKTOP CHARGER WOULD NOT CHARGE THE RECHARGER. THEY PULLED THE METAL PIECE OUT OF THE RECHARGER AND TRIED TO PUT IT BACK ON THE PLUG. THE PROGRAMMER WOULD NOT COMMUNICATE OR SYNC WITH THE IMPLANTABLE NEUROSTIMULATOR (INS). THEY WERE SENT A REPLACEMENT DESKTOP CHARGER. THE PATIENT WAS IMPLANTED FOR SPINAL PAIN.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED FROM THE HEALTHCARE PROVIDER (HCP) REPORTED THE CONSUMER HADN'T CALLED OR BEEN SEEN IN THEIR OFFICE SINCE (B)(6) 2012.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    200954 RESTORE SENSOR STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37714

    Patients

    Seq Age Sex Outcome Treatment
    1 00041 YR