BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORE

    MDR report key: 3467739 · Received November 13, 2013

    Report

    Report Number
    3004209178-2013-20752
    Event Type
    Injury
    Date Received
    November 13, 2013
    Report Date
    October 25, 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
    MO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID 377875 LOT# V003908, IMPLANTED: 2006 (B)(6); PRODUCT TYPE LEAD PRODUCT ID 355029 LOT# N070935, IMPLANTED: 2006 (B)(6); PRODUCT TYPE ACCESSORY. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4)

    Description of Event or Problem · 1

    IT WAS REPORTED THAT IN (B)(6) 2005 A PATIENT HAD A DEVICE IMPLANTED. THE PATIENT STATED ¿HE DIDN¿T TEST IT SO IT DIDN¿T WORK¿ AND ¿THEY HAD TO PUT IN AGAIN 4 MONTHS LATER. PATIENT STATED THE FIRST ONE WAS COMPLETELY DEAD AND IT WAS NOTHING.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT HAD LEAD MIGRATION. LEADS WERE DISLODGED. THE IMPLANTABLE NEUROSTIMULATOR AND LEADS WERE REPLACED ON 2007-(B)(6). THE HEALTH CARE PROFESSIONAL DID AND X-RAY SHOW LEAD MIGRATION. THE PATIENT REQUIRED HOSPITALIZATION DUE TO THIS EVENT. THE PATIENT RECOVERED WITHOUT SEQUELAE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    586933 RESTORE STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37711

    Patients

    Seq Age Sex Outcome Treatment
    1 00039 YR Hospitalization| R