BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORE SENSOR

    MDR report key: 3949240 · Received July 22, 2014

    Report

    Report Number
    3004209178-2014-13333
    Event Type
    Injury
    Date Received
    July 22, 2014
    Report Date
    July 9, 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
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID 3708220, SERIAL # (B)(4), IMPLANTED: (B)(6) 2014, PRODUCT TYPE EXTENSION; PRODUCT ID 3708240, SERIAL # (B)(6), IMPLANTED: (B)(6) 2014, PRODUCT TYPE EXTENSION; PRODUCT ID 3888-33, LOT # VA0CNV5, IMPLANTED: (B)(6) 2014, PRODUCT TYPE LEAD; PRODUCT ID 3888-45, LOT # V994388, IMPLANTED: (B)(6) 2014, PRODUCT TYPE LEAD; PRODUCT ID 3998, LOT # VA0855Q, IMPLANTED: (B)(6) 2014, PRODUCT TYPE LEAD; PRODUCT ID 97754, SERIAL # (B)(4), PRODUCT TYPE RECHARGER. (B)(4).

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE PATIENT¿S ISSUE WAS NOT RELATED TO THE DEVICE AND IT WOULD NOT BE RETURNED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD A LOSS OF THERAPEUTIC EFFECT. IT WAS STATED THAT IT WAS FINE FOR A COUPLE OF MONTHS AND THEN STARTED BOTHERING HER. THE PATIENT WANTED TO KNOW WHO SHE COULD SPEAK TO ABOUT DOING AN EXPLANT. THE PATIENT WAS REDIRECTED TO HER PHYSICIAN. WHEN THE PATIENT USED THE DEVICE, IT DID NOT DO ANY GOOD. THE STIMULATOR WAS PUSHING OUT OF HER SKIN AND WAS PAINFUL. THE PATIENT STATED THAT IT MAY BE PRESSING ON A NERVE BECAUSE IT FELT LIKE HER LEG WAS GOING TO ¿FALLOFF¿ OR ¿EXPLODE.¿ OF NOTE, THE PATIENT HAD PREVIOUS ANKLE HARDWARE TRY TO PUSH ITSELF THROUGH THE SKIN. IN ADDITION, THE PATIENT COULDN¿T GET ANY CONNECTION TO CHARGE. IT WAS FURTHER REPORTED THAT THE PATIENT HAD AN APPOINTMENT ON (B)(6) 2014 TO DISCUSS REMOVING THE DEVICE. IT WAS FURTHER REPORTED THAT THE SYSTEM WAS REMOVED ON (B)(6) 2014. ADDITIONAL INFORMATION WAS REQUESTED, IF RECEIVED A FOLLOW UP REPORT WILL BE SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    427116 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 00058 YR Required Intervention