BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE

    MDR report key: 3031172 · Received April 2, 2013

    Report

    Report Number
    3004209178-2013-04487
    Event Type
    Malfunction
    Date Received
    April 2, 2013
    Report Date
    March 13, 2013
    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
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    PRODUCT ID 37752 LOT# SERIAL# (B)(4), IMPLANTED: 2007 (B)(6), PRODUCT TYPE RECHARGER PRODUCT ID 377660 LOT# V021032, IMPLANTED: 2007 (B)(6), PRODUCT TYPE LEAD PRODUCT ID 377660 LOT# V017176, IMPLANTED: 2007 (B)(6), PRODUCT TYPE LEAD PRODUCT ID 37742 LOT# SERIAL# (B)(4), IMPLANTED: 2007 (B)(6), PRODUCT TYPE PROGRAMMER, PATIENT. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WERE TELEMETRY ISSUES AND A SUSPECTED OVERDISCHARGE. IT WAS STATED THAT WHEN THE PATIENT "REACHED HER NECK BACK -- SHE FELT STIMULATION". IT WAS CONFIRMED THE PATIENT FELT STIMULATION IN HER LEGS, DESPITE "NO COMMUNICATION". THE PATIENT STATED THAT SHE FELL A WEEK PRIOR TO REPORT, BUT THE DETAILS WERE UNKNOWN. IT WAS ALSO STATED THAT THE IMPLANTABLE NEUROSTIMULATOR (INS) WAS UNABLE TO BE READ WITH THE PROGRAMMER AND RECHARGER. IT WAS NOTED THAT THE PATIENT CHARGED HER INS EVERY TWO WEEKS. AN OVERDISCHARGE WAS SUSPECTED AND THE PATIENT WAS REDIRECTED TO HER HEALTHCARE PROVIDER. ADDITIONAL INFORMATION WAS REQUESTED AND IF RECEIVED, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE DEVICE BATTERY WAS COMPLETELY OVERDISCHARGED, THE PATIENT WAS "IN THE OFFICE FOR HOURS" AND THE DEVICE BATTERY ¿WOULD NOT COME BACK.¿ IT WAS NOTED THAT THE PATIENT WASN¿T SURE IF SHE WANTED TO REPLACE THE DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    135291 RESTORE STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37711

    Patients

    Seq Age Sex Outcome Treatment
    1 00060 YR