BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORE SENSOR

    MDR report key: 3874469 · Received June 16, 2014

    Report

    Report Number
    3004209178-2014-11621
    Event Type
    Injury
    Date Received
    June 16, 2014
    Report Date
    June 3, 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
    OR, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID 37754, SERIAL# (B)(4), PRODUCT TYPE RECHARGER; PRODUCT ID 37746, SERIAL# (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT; PRODUCT ID 39565-65, SERIAL# (B)(4), IMPLANTED: (B)(6) 2013, PRODUCT TYPE LEAD. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD FALLEN A FEW MONTHS PRIOR TO THE DATE OF THIS REPORT AND THE PATIENT¿S HEALTHCARE PROVIDER (HCP) HAD FOUND THAT HER IMPLANTABLE NEUROSTIMULATOR (INS) HAD FLIPPED OVER. IT WAS STATED THAT THE PATIENT HAD SURGERY ON (B)(6) 2014 TO REPAIR IT. IT WAS STATED THAT THE PATIENT WAS SLOW AND WOULD TAKE A WHILE TO MOVE WITH ALL OF HER PAIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    352597 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 00090 YR Required Intervention