BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORE SENSOR MRI

    MDR report key: 4100029 · Received September 18, 2014

    Report

    Report Number
    3004209178-2014-17333
    Event Type
    Injury
    Date Received
    September 18, 2014
    Report Date
    August 26, 2014
    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

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 39286-65, SERIAL# (B)(4), IMPLANTED: (B)(6) 2013, PRODUCT TYPE: LEAD. (B)(4).

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THE PHYSICIAN¿S OFFICE HAD CALLED THE PATIENT A NUMBER OF TIMES TO SCHEDULE AN APPOINTMENT TO SEE THE PATIENT AND SET UP A REPLACEMENT. THE PATIENT HAD NOT RETURNED THE PHYSICIAN¿S PHONE CALLS.

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT HAD NOT USED HER IMPLANTABLE NEUROSTIMULATOR (INS) IN THE PAST 3 MONTHS AS SHE WAS HOSPITALIZED IN THE (B)(6) TIME FRAME. THE PATIENT WAS IN THE HOSPITAL FOR OTHER MEDICAL PROBLEMS. THERE WERE TELEMETRY ISSUES WITH THE INS AND THE BATTERY WAS IN OVERDISCHARGE. THE LAST SUCCESSFUL CHARGING SESSION AND LAST TIME STIMULATION WAS FELT WAS IN MAY, AS THE PATIENT DID NOT OPERATE HER INS WHILE HOSPITALIZED. WITH THE REP¿S INSTRUCTION, THE PATIENT DID 4 BACK TO BACK PHYSICIAN MODE RECHARGES (PMR) WHICH WERE UNSUCCESSFUL IN "WAKING UP THE BATTERY." THE NORMAL CHARGING SCREEN WAS NOT SEEN. HOWEVER, IT WAS REPORTED THAT THE PATIENT WAS SCHEDULED FOR A CONSULT WITH THE PHYSICIAN SO HE COULD DICTATE A NOTE TO ESTABLISH AUTHORIZATION FOR SURGERY TO REPLACE THE BATTERY. IT WAS NOTED THE DEVICE HAD NOT REPLACED AT THE TIME OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    578325 RESTORE SENSOR MRI STIMULATOR, SPINAL-CORD, IMPLANTED (PAIN RELIEF) LGW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 97714

    Patients

    Seq Age Sex Outcome Treatment
    1 00060 YR Required Intervention