BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORE SENSOR

    MDR report key: 3100402 · Received May 8, 2013

    Report

    Report Number
    3004209178-2013-07395
    Event Type
    Injury
    Date Received
    May 8, 2013
    Report Date
    April 16, 2013
    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
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THERE WAS EROSION AT THE IMPLANT POCKET AND THE IMPLANTABLE NEUROSTIMULATOR (INS) WAS "TILTED AND POKING TOWARDS THE SKIN." IT WAS NOTED THERE WAS NO OPEN SORE, BUT THE INS WAS GOING TO BE REPOSITIONED TO AVOID FURTHER COMPLICATION. IT WAS FURTHER NOTED THE PATIENT EXPERIENCED PAIN AT THE DEVICE POCKET.

    Description of Event or Problem · 1

    IT WAS FURTHER REPORTED THAT THE SURGERY TO REPOSITION THE INS WAS SUCCESSFUL. THE MANUFACTURER REPRESENTATIVE LAST HAD CONTACT WITH THE PATIENT ON 2013-(B)(6) AND AT THAT TIME THEY WERE GETTING EFFECTIVE THERAPY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    201656 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 00075 YR Required Intervention