BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORE SENSOR

    MDR report key: 3022069 · Received March 26, 2013

    Report

    Report Number
    3004209178-2013-04270
    Event Type
    Injury
    Date Received
    March 26, 2013
    Report Date
    March 8, 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
    OR, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID 3550-39, LOT# N355697, IMPLANTED: (B)(6) 2012, PRODUCT TYPE ACCESSORY; PRODUCT ID 3 7746, SERIAL# (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT; PRODUCT ID 37754, SERIAL# (B)(4), PRODUCT TYPE RECHARGER; PRODUCT ID 3778-60, SERIAL# (B)(4), IMPLANTED: (B)(6) 2012, PRODUCT TYPE LEAD; PRODUCT ID 3778-60, SERIAL# (B)(4), IMPLANTED: (B)(6) 2012, PRODUCT TYPE LEAD. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT EXPERIENCED STIMULATION IN THE WRONG LOCATION. IT WAS STATED THAT THERE WAS A LEAD REVISION SURGERY DONE ON (B)(6) 2013. REPORTEDLY, DURING SURGERY THE HEALTHCARE PROVIDER (HCP) NOTICED THAT THE PERMANENT SUTURES AROUND THE ANCHOR HAD DISINTEGRATED. IT WAS NOTED THAT THE HCP REPOSITIONED THE LEAD AND RE-SUTURED THE ANCHOR. IT WAS STATED THAT THE PATIENT WAS GETTING "GREAT" COVERAGE AT THE TIME OF REPORT. IF ADDITIONAL INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE FILED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    123415 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 00066 YR Required Intervention