BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE SENSOR

    MDR report key: 2993157 · Received March 7, 2013

    Report

    Report Number
    3004209178-2013-03452
    Event Type
    Malfunction
    Date Received
    March 7, 2013
    Date of Event
    February 13, 2013
    Report Date
    February 14, 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
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    PRODUCT ID: 39286-65 LOT# SERIAL# (B)(4), IMPLANTED: 2012 (B)(6), PRODUCT TYPE LEAD PRODUCT ID: 37754 LOT# SERIAL# (B)(4), PRODUCT TYPE RECHARGER PRODUCT ID: 37746 LOT# SERIAL# (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT¿S IMPLANTABLE NEUROSTIMULATOR (INS) KEPT ¿TURNING UP¿. IT WAS NOTED THAT THE PATIENT WOULD ¿TURN IT DOWN¿ TO 2.5 VOLTS AND TEN MINUTES LATER, THE STIMULATION ¿JUMPS BACK UP¿ TO 3.5 VOLTS. IT WAS REPORTED THAT THIS OCCURRED ON ALL PROGRAMS. IT WAS NOTED THAT THIS STARTED THE DAY PRIOR TO THE REPORT. IT WAS NOTED THE PATIENT DOES HAVE A DEVICE WITH ¿ADAPTIVE STIM¿ BUT STATES SHE ¿NEVER GOT IT ACTIVATED¿. IT WAS REPORTED THE PATIENT DID NOT HAVE A REPROGRAMMING SESSION SINCE IMPLANT. IT WAS NOTED THAT THE PATIENT DID NOT HAVE ANY RECENT FALLS OR TRAUMA. IT WAS REPORTED THAT THE PATIENT EXPERIENCED AN OVERSTIMULATION SENSATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS AN OVERSTIMULATION SENSATION. IT WAS STATED THAT THE STIMULATION WAS TURNING UP "ON ITS OWN". IT WAS ALSO STATED THAT THE PATIENT TURNED HER STIMULATION ON ALL PROGRAMS DOWN TO 2.5 VOLTS, ABOUT TEN MINUTES LATER, SHE FELT HER STIMULATION INCREASE AND VERIFIED VIA PATIENT PROGRAMMER THE VOLTAGE WAS UP TO 3.5. THE PATIENT WAS REDIRECTED TO HER HEALTHCARE PROVIDER. IF ADDITIONAL INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE FILED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    98136 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 00040 YR