BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORE

    MDR report key: 2982630 · Received February 28, 2013

    Report

    Report Number
    3004209178-2013-03146
    Event Type
    Injury
    Date Received
    February 28, 2013
    Report Date
    February 7, 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 3778-60, SERIAL# (B)(4), IMPLANTED: (B)(6) 2010, PRODUCT TYPE LEAD; PRODUCT ID 37752, SERIAL# (B)(4), PRODUCT TYPE RECHARGER; PRODUCT ID 37743, SERIAL# (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE CALLER THE PHYSICIAN DETERMINED THE IMPLANTABLE NEUROSTIMULATOR (INS) WAS 'TOO BIG' FOR THE PATIENT. THE PATIENT, REPORTEDLY, COMPLAINED THE DEVICE SITE WAS 'HURTING AND RUBBING' SINCE IT WAS IMPLANTED. IT WAS STATED THE PATIENT ALSO EXPERIENCED 'POSITIONAL CHANGES NOT COMFORTABLY ALLOWING HER TO KEEP ON AT NIGHT.' THE DEVICE WAS REPLACED WITH A SMALLER BATTERY. NO OTHER INFORMATION WAS PROVIDED. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, A SUPPLEMENTAL REPORT WILL BE FILED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    87788 RESTORE STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37711

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention