BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE

    MDR report key: 3082592 · Received April 29, 2013

    Report

    Report Number
    3004209178-2013-07010
    Event Type
    Malfunction
    Date Received
    April 29, 2013
    Report Date
    April 11, 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
    WA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID 3708340, SERIAL# (B)(4), IMPLANTED: (B)(6) 2006, PRODUCT TYPE EXTENSION; PRODUCT ID 37752, SERIAL# (B)(4), IMPLANTED: (B)(6) 2006, PRODUCT TYPE RECHARGER; PRODUCT ID 3708340, SERIAL# (B)(4), IMPLANTED: (B)(6) 2006, PRODUCT TYPE EXTENSION; PRODUCT ID 37742, SERIAL# (B)(4), IMPLANTED: (B)(6) 2006, PRODUCT TYPE PROGRAMMER, PATIENT; PRODUCT ID 389033, LOT# J0333965V, IMPLANTED: (B)(6) 2003, PRODUCT TYPE LEAD; PRODUCT ID 389033, LOT# J0337523V, IMPLANTED: (B)(6) 2003, PRODUCT TYPE LEAD; PRODUCT ID 389033, LOT# J0340371V, IMPLANTED: (B)(6) 2003, PRODUCT TYPE LEAD. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION REPORTED THAT THE STIMULATOR WASN¿T WORKING.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT TWO ELECTRODES WERE NOT WORKING WELL TO COVER HER PAIN AND THAT THE MANUFACTURER REPRESENTATIVE HAD TO PROGRAM HER DIFFERENTLY. THE PATIENT COULD NOT REMEMBER WHEN THIS TOOK PLACE, BUT THAT THE REPROGRAMMING RESOLVED THE ISSUE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE 3 YEARS AGO, THE PATIENT'S LEAD BROKE, AND THERE WAS A LOSS OF THERAPY. IT WAS STATED THAT ADJUSTMENTS WERE MADE AND THE MANUFACTURER REPRESENTATIVE WAS ABLE TO GET ANOTHER LEAD TO COVER THE PAIN. ADDITIONAL INFORMATION HAD BEEN REQUESTED, BUT WAS UNAVAILABLE AT THE DATE OF THIS REPORT. ANY ADDITIONAL INFORMATION RECEIVED WILL BE INCLUDED IN A SUPPLEMENTAL REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    183981 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