BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORE SENSOR

    MDR report key: 2873806 · Received December 14, 2012

    Report

    Report Number
    3004209178-2012-11835
    Event Type
    Injury
    Date Received
    December 14, 2012
    Report Date
    November 23, 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
    WV, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    PRODUCT ID 3778-60, SERIAL# (B)(4), IMPLANTED: 2012 (B)(6), PRODUCT TYPE LEAD, PRODUCT ID 37754, SERIAL# (B)(4), PRODUCT TYPE RECHARGER, PRODUCT ID 37746, SERIAL# (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT. (B)(4).

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED INDICATED THAT THE SYSTEM WAS REPLACED IN (B)(6) 2013. IT WAS STATED THAT SYSTEM WENT UP TO PATIENT'S NECK BECAUSE IT WASN'T PROPERLY SECURED.

    Description of Event or Problem · 1

    IT WAS REPORTED THERE WAS A LEAD MIGRATION. THE LEAD HAD MIGRATED FROM T8 TO T3 SOMETIME AFTER IMPLANT. AS A RESULT, STIMULATION WAS NOT COVERING PAIN AREA. THE PATIENT WAS NOT RECEIVING STIMULATION AND WILL REQUIRE SURGERY TO REPAIR SPINAL CORD STIMULATION SYSTEM FUNCTIONALITY. LEAD REVISION SURGERY WAS PLANNED BUT NOT SCHEDULED AS OF THE TIME OF REPORT. PATIENT SYMPTOMS INCLUDED LESS THAN 50% THERAPY RELIEF, AND THE LOCATION OF THE SYMPTOMS WAS UNKNOWN. ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT WAS 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 00038 YR Required Intervention