BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE SENSOR

    MDR report key: 2670812 · Received July 26, 2012

    Report

    Report Number
    3004209178-2012-06108
    Event Type
    Malfunction
    Date Received
    July 26, 2012
    Report Date
    June 28, 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
    NJ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 3778-60, SERIAL# (B)(4), IMPLANTED: (B)(6) 2008. PRODUCT TYPE: LEAD: PRODUCT ID 37754, SERIAL# (B)(4). PRODUCT TYPE: RECHARGER: PRODUCT ID 37742, SERIAL# (B)(4), IMPLANTED: (B)(6) 2008. PRODUCT TYPE: PROGRAMMER, PATIENT: PRODUCT ID 3550-29, LOT# N130238, IMPLANTED: (B)(6) 2008. PRODUCT TYPE: ACCESSORY. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT'S IMPLANTED DEVICE WAS "PROTRUDING." THE PATIENT EXPERIENCED A "BURNING SENSATION AT THE INTERNAL NEUROSTIMULATOR (INS) SITE" AND WAS NOT ABLE TO LIE ON HER BACK. THE PATIENT STATED THAT "HER SON THOUGHT THAT MAYBE HER BODY WAS REJECTING THE INS." IT WAS FURTHER NOTED THAT SINCE (B)(6) 2012 THE PATIENT WAS "GETTING ZAPS" WHEN THE STIMULATOR WAS ON. THE PATIENT DID NOT REPORT ANY FALLS OR TRAUMA ASSOCIATED WITH THE EVENT. THE PATIENT OUTCOME WAS NOT PROVIDED. ADDITIONAL INFORMATION WAS REQUESTED BUT NOT AVAILABLE AS OF THE DATE OF THIS REPORT.

    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