BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORE ULTRA

    MDR report key: 2935714 · Received January 30, 2013

    Report

    Report Number
    3004209178-2013-01131
    Event Type
    Injury
    Date Received
    January 30, 2013
    Report Date
    January 9, 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 MEDICAL PRODUCTS: PRODUCT ID 3888-56, LOT# V086944, IMPLANTED: (B)(6) 2008. PRODUCT TYPE: LEAD: PRODUCT ID 3888-45, LOT# V079881, IMPLANTED: (B)(6) 2008. PRODUCT TYPE: LEAD: PRODUCT ID 3888-45, LOT# V079881, IMPLANTED: (B)(6) 2008. PRODUCT TYPE: LEAD: PRODUCT ID 3888-45, LOT# V067339, IMPLANTED: (B)(6) 2008. PRODUCT TYPE: LEAD: PRODUCT ID 37752, SERIAL# (B)(4), IMPLANTED: (B)(6) 2008. PRODUCT TYPE: RECHARGER: PRODUCT ID 37743, SERIAL# (B)(4), IMPLANTED: (B)(6) 2008. PRODUCT TYPE: PROGRAMMER, PATIENT: PRODUCT ID 3708220, SERIAL# (B)(4), IMPLANTED: (B)(6) 2008, EXPLANTED: (B)(6) 2013. PRODUCT TYPE: EXTENSION: PRODUCT ID 3708220, SERIAL# (B)(4), IMPLANTED: (B)(6) 2008, EXPLANTED: (B)(6) 2013. PRODUCT TYPE: EXTENSION. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WANTED A "LARGER" IMPLANTABLE NEUROSTIMULATOR (INS) TO BE ABLE TO RECHARGE "MORE EASILY" AND TO HOLD A CHARGE "LONGER". THE PATIENT ALSO DESIRED TO HAVE THE INS MOVED TO HIS ABDOMEN. THE PATIENT'S INS AND EXTENSIONS WERE REPLACED. THERE WERE NO PATIENT SYMPTOMS OR INJURIES RELATED TO THE EVENT BUT SURGICAL INTERVENTION WAS REQUIRED. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    FOLLOW UP INFORMATION RECEIVED REPORTED THAT THE PATIENT WAS DOING WELL WITH THEIR THERAPY. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW UP REPORT WILL BE SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    40554 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