BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORE SENSOR

    MDR report key: 4210669 · Received October 29, 2014

    Report

    Report Number
    3004209178-2014-20608
    Event Type
    Injury
    Date Received
    October 29, 2014
    Report Date
    October 13, 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
    AR, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID: 39565-65, SERIAL# (B)(4), IMPLANTED: (B)(6) 2012, PRODUCT TYPE: LEAD. PRODUCT ID: 39565-65, SERIAL# (B)(4), IMPLANTED: (B)(6) 2012, PRODUCT TYPE: LEAD. PRODUCT ID: 37754, SERIAL# (B)(4), PRODUCT TYPE: RECHARGER. PRODUCT ID: 37744, SERIAL# (B)(4), PRODUCT TYPE: PROGRAMMER, PATIENT. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE IMPLANTABLE NEUROSTIMULATOR (INS) WAS EXPLANTED APPROXIMATELY 6-8 WEEKS AFTER IMPLANT, DUE TO PAIN CAUSED BY THE PLACEMENT OF THE DEVICE. THE PATIENT WAS REPORTEDLY TINY AND THE INS WAS PLACED IN THE ¿BUTTOCK CHEEK AREA¿. WHEN THE PATIENT SAT DOWN, THE INS WOULD MOVE, WHICH "JARRED" THE WIRING AND, THEN, IT WOULD ¿HURT LIKE CRAZY¿. FOLLOW-UP IS BEING CONDUCTED TO PROVIDE ADDITIONAL INFORMATION SURROUNDING THE EVENT. IF THIS INFORMATION BECOMES AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    693879 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 00048 YR Required Intervention