BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORE SENSOR

    MDR report key: 3894992 · Received June 25, 2014

    Report

    Report Number
    3004209178-2014-12051
    Event Type
    Injury
    Date Received
    June 25, 2014
    Report Date
    June 4, 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
    NJ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    PRODUCT ID: 37754, SERIAL# (B)(4), PRODUCT TYPE: RECHARGER. PRODUCT ID: 37746, SERIAL# (B)(4), PRODUCT TYPE: PROGRAMMER. PATIENT PRODUCT ID: 39286-65, SERIAL# (B)(4), IMPLANTED: (B)(6) 2013, PRODUCT TYPE: LEAD.

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT¿S HAD THEIR SPINAL CORD STIMULATOR REMOVED DUE TO THE FACT ¿IT DID NOT WORK.¿

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE PATIENT'S DEVICE WAS REMOVED IN (B)(6) 2013. THE PATIENT'S DEVICE WAS HELPING WITH PAIN CONTROL UNTIL (B)(6) 2013. IT STOPPED HELPING WITH THE PAIN AND WAS NOT DOING WHAT IT WAS SUPPOSED TO. IT MADE THINGS WORSE AT ONE POINT. IT DID NOT EVEN HIDE THE PAIN AND IT MADE IT FEEL LESS THAN IT WAS. ADJUSTMENTS WERE MADE A COUPLE OF DIFFERENT TIMES BUT IT DID NOT RESOLVE THE ISSUE. IT WAS FURTHER NOTED THAT THE IMPLANTABLE NEUROSTIMULATOR (INS) TURNED THE PATIENT'S RIGHT ARM NUMB. THE PATIENT'S ARM WENT BACK TO NORMAL ONCE THE DEVICE WAS REMOVED. IF ADDITIONAL INFORMATION IS RECEIVED, THE EVENT WILL BE UPDATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    371608 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 Required Intervention