BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE

    MDR report key: 3092192 · Received May 3, 2013

    Report

    Report Number
    3004209178-2013-07257
    Event Type
    Malfunction
    Date Received
    May 3, 2013
    Report Date
    April 16, 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
    AZ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 3887-33, LOT# J0222748V. PRODUCT TYPE: LEAD: PRODUCT ID 3708140, SERIAL# (B)(4). PRODUCT TYPE: EXTENSION: PRODUCT ID 37752, SERIAL# (B)(4). PRODUCT TYPE: RECHARGER: PRODUCT ID 3708360, SERIAL# (B)(4). PRODUCT TYPE: EXTENSION: PRODUCT ID 377875, LOT# J0555561V. PRODUCT TYPE: LEAD: PRODUCT ID 37742, SERIAL# (B)(4). PRODUCT TYPE: PROGRAMMER, PATIENT. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT IN (B)(6) 2007 THE PATIENT WAS CUT OPEN 14 INCHES AND FULLY FUSED FROM SACRUM TO T10. THE SURGERY WAS NOT REPORTED TO HAVE BEEN DEVICE RELATED. WHEN THE PHYSICIAN PERFORMED THE SURGERY, "HE HAD TO MOVE" AND IT NEVER WORKED RIGHT AFTER THE BACK SURGERY. IT WAS REPORTED IT DID NOT "HIT THE RIGHT SPOTS" ALTHOUGH IT HAD WORKED BEFORE. ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    193768 RESTORE STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37711

    Patients

    Seq Age Sex Outcome Treatment
    1