BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE

    MDR report key: 2970020 · Received February 20, 2013

    Report

    Report Number
    3004209178-2013-02896
    Event Type
    Malfunction
    Date Received
    February 20, 2013
    Report Date
    September 5, 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
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID 3998, LOT# J0543044V, IMPLANTED: (B)(6) 2005, PRODUCT TYPE: LEAD. PRODUCT ID 37752, SERIAL# (B)(4), IMPLANTED: (B)(6) 2006, PRODUCT TYPE: RECHARGER. PRODUCT ID 37742, SERIAL# (B)(4), IMPLANTED: (B)(6) 2006, PRODUCT TYPE: PROGRAMMER, PATIENT. PRODUCT ID 3708260,# SERIAL# (B)(4), IMPLANTED: (B)(6) 2006, PRODUCT TYPE: EXTENSION. (B)(4)

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD FALLEN A LITTLE OVER A YEAR PRIOR TO THIS REPORT AND WASN'T ABLE TO RECHARGE THEIR IMPLANTABLE NEUROSTIMULATOR (INS) SINCE. IT WAS STATED THAT THE PATIENT "FELL AND COULD NOT CHARGE IT". IT WAS NOTED THAT THE DEVICE "FELL OUT OF THE POCKET". IT WAS STATED THAT THE PHYSICIAN MODE RESETS WERE NOT SUCCESSFUL. IT WAS NOTED THAT THE HEALTH CARE PROVIDER THOUGHT THE INS CANNOT BE "BROUGHT BACK" AND MUST BE REPLACED. THE CALLER WAS REDIRECTED TO THE PATIENT'S HEALTH CARE PROVIDER. ADDITIONAL INFORMATION HAS BEEN REQUESTED. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, A SUPPLEMENTAL REPORT WILL BE FILED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    73527 RESTORE STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37711

    Patients

    Seq Age Sex Outcome Treatment
    1