BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORE SENSOR

    MDR report key: 2955697 · Received February 11, 2013

    Report

    Report Number
    3004209178-2013-02533
    Event Type
    Injury
    Date Received
    February 11, 2013
    Report Date
    January 26, 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
    IA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    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).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT'S DEVICE WAS REVISED IN OCTOBER BECAUSE IT WAS TOO FAR UNDERNEATH THE TISSUE. A SUPPLEMENTAL REPORT WILL BE SENT IF ANY ADDITIONAL INFORMATION IS RECEIVED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE CAUSE OF THE EVENT WAS THAT THE BATTERY WOULD NOT CHARGE. ON (B)(6) 2012 THE IMPLANT LOCATION WAS REVISED FROM 2CM DEEP TO 1CM DEEP. FOLLOWING THE REVISION THE BATTERY RECHARGED. IT WAS REPORTED THAT THE PATIENT REQUIRED HOSPITALIZATION, BUT RECOVERED WITHOUT SEQUELA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    59391 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 Hospitalization| R