BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORE ULTRA

    MDR report key: 3051597 · Received April 10, 2013

    Report

    Report Number
    3004209178-2013-05971
    Event Type
    Injury
    Date Received
    April 10, 2013
    Report Date
    March 26, 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 37744, SERIAL# (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT; PRODUCT ID 37754, SERIAL# (B)(4), PRODUCT TYPE RECHARGER; PRODUCT ID 39286-65, SERIAL# (B)(4), IMPLANTED: (B)(6) 2012, PRODUCT TYPE LEAD. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WAS UNABLE TO OBTAIN MORE THAN 2 TO 4 COUPLING BARS AND HAD MUCH DIFFICULTY GETTING THAT SINCE SHE WAS IMPLANTED. EVEN WITH OBTAINING THAT, THE PATIENT COULD REPORTEDLY NOT KEEP THE COUPLING BARS TO STAY. THE REPORTER STATED THAT THIS HAD BEEN CONFIRMED A FEW TIMES IN THE PAST. AT THE PATIENT'S POCKET REVISION SURGERY, AN ATTEMPT WAS MADE WITH A DIFFERENT RECHARGER BUT IT WAS ONLY POSSIBLE TO GET TWO COUPLING BARS, 4 WITH PRESSURE. IT WAS HOWEVER NOT POSSIBLE TO MAINTAIN THE COUPLING BARS. THERE WERE NO PATIENT SYMPTOMS OR INJURIES RELATED TO THIS EVENT. HOWEVER, THE IMPLANTABLE NEUROSTIMULATOR (INS) WAS CONSEQUENTLY REPOSITIONED. EIGHT COUPLING BARS WERE OBTAINED POST-OPERATIVELY IN BOTH A LYING AND SITTING POSITION. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    153268 RESTORE ULTRA STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37712

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention