BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORE

    MDR report key: 3062702 · Received April 17, 2013

    Report

    Report Number
    3004209178-2013-06417
    Event Type
    Injury
    Date Received
    April 17, 2013
    Report Date
    March 20, 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

    CONCOMITANT PRODUCTS: PRODUCT ID 3887-33, SERIAL# (B)(4), IMPLANTED: (B)(6) 2002, PRODUCT TYPE LEAD; PRODUCT ID 3708220, SERIAL# (B)(4); PRODUCT ID 3708220, SERIAL# (B)(4), EXPLANTED: (B)(6) 2013, PRODUCT TYPE EXTENSION; PRODUCT ID 3887-33, SERIAL# (B)(4), IMPLANTED: (B)(6) 2002, EXPLANTED: (B)(6) 2013, PRODUCT TYPE LEAD.

    Additional Manufacturer Narrative · 1

    PRODUCT ID: 3887-33, LOT# J0220178V, IMPLANTED: (B)(6) 2002, PRODUCT TYPE: LEAD. PRODUCT ID: 3708220, SERIAL# (B)(4), IMPLANTED: (B)(6) 2006, PRODUCT TYPE: EXTENSION. PRODUCT ID: NEU_UNKNOWN_LEAD, PRODUCT TYPE: LEAD. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WAS SCHEDULED FOR REPLACEMENT OF HER IMPLANTABLE NEUROSTIMULATOR (INS) ON (B)(6) 2013. THE REPORTER INDICATED THAT TWO LEADS WERE GOING TO BE IMPLANTED AT THAT TIME AS WELL. IT WAS UNKNOWN AT THE TIME WHAT THE REASON FOR THE REPLACEMENT WAS. APPROXIMATELY TWO WEEKS LATER, IT WAS REPORTED THAT THE PATIENT WAS HAVING THE REPLACEMENT SURGERY ON THE DAY OF THE REPORT. THE PATIENT'S LEADS WERE REPORTEDLY 13 YEARS OLD AND ONLY 2 OF THE EIGHT ELECTRODES ON ONE OF THE LEADS WERE WORKING. IT WAS NOTED THAT THE PATIENT WAS HAPPY FOLLOWING THE REPLACEMENT SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    165131 RESTORE STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37711

    Patients

    Seq Age Sex Outcome Treatment
    1 00048 YR Required Intervention