BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE SENSOR

    MDR report key: 2614545 · Received June 13, 2012

    Report

    Report Number
    3004209178-2012-04394
    Event Type
    Malfunction
    Date Received
    June 13, 2012
    Report Date
    May 17, 2012
    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
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID 3888-45, LOT# V851636, IMPLANTED: (B)(6) 2012. PRODUCT TYPE: LEAD: PRODUCT ID 3888-33, LOT# V855431, IMPLANTED: (B)(6) 2012. PRODUCT TYPE: LEAD: PRODUCT ID 37754, SERIAL# (B)(4). PRODUCT TYPE: RECHARGER: PRODUCT ID 37744, SERIAL# (B)(4). PRODUCT TYPE: PROGRAMMER, PATIENT: PRODUCT ID 3708220, SERIAL# (B)(4), IMPLANTED: (B)(6) 2012. PRODUCT TYPE: EXTENSION: PRODUCT ID 3708220, SERIAL# (B)(4), IMPLANTED: (B)(6) 2012. PRODUCT TYP: EXTENSION: PRODUCT ID 3487A-45, LOT# V820870, IMPLANTED: (B)(6) 2012. PRODUCT TYPE: LEAD: PRODUCT ID 3487A-45, LOT# V820870, IMPLANTED: (B)(4) 2012. PRODUCT TYPE: LEAD. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHEN THE PATIENT WAS STANDING, THE INTERNAL NEUROSTIMULATOR (INS) SETTING WAS TOO HIGH PATIENT HAD TRIPPED ON AN EXTENSION CORD AND NEEDED TO INCREASE THE STIMULATION TO COVER HER PAIN. HOWEVER, NOW THE STIMULATION WAS TOO HIGH. THE PATIENT ATTEMPTED TO REPROGRAM THE INS BUT THE SETTING HAD NOT BEEN MAINTAINED. THE PATIENT HAD NOT TIMED HER POSITION. TO REPROGRAM THE INS THE PATIENT HAD TO STAY IN THE DESIRED BODY POSITION FOR THREE MINUTES NOT THREE SECONDS. PATIENT OUTCOME WAS NOT PROVIDED. ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED NOTED THAT THE PATIENT DID NOT HAVE CONCERNS WITH THEIR DEVICE OR THERAPY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 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