BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORE ADVANCED

    MDR report key: 3113690 · Received May 15, 2013

    Report

    Report Number
    3004209178-2013-07700
    Event Type
    Injury
    Date Received
    May 15, 2013
    Report Date
    April 29, 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
    TN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID 39565-30, SERIAL# (B)(4), IMPLANTED: (B)(6) 2008, PRODUCT TYPE LEAD; PRODUCT ID 37743, SERIAL# (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT; PRODUCT ID 37752, SERIAL# (B)(4), IMPLANTED: (B)(6) 2008, PRODUCT TYPE RECHARGER. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION REPORTED INDICATED THAT THE PATIENT WAS SEEN ON THE DAY OF THE REPORT AND THERE WERE STILL SAME IMPEDANCES "PER EARLIER PRINTOUT." THERE WERE AGAIN COMPLAINTS OF NEEDING TO TURN DEVICE UP FOR COVERAGE, WITH ASSOCIATED STINGING SENSATIONS IN THE BACK. THE INS (IMPLANTABLE NEUROSTIMULATOR) WAS SUCCESSFULLY REPROGRAMMED FOR BETTER COVERAGE OF PAINFUL AREAS WITHOUT DISCOMFORT OR STINGING SENSATION. THE PATIENT HAD LOST QUITE A BIT OF WEIGHT, AND HER INS HAD MIGRATED DIRECTLY TO THE LEFT OF HER SPINE. IT WAS STATED THAT THE PATIENT MIGHT WANT DEVICE POCKET MOVED IN THE FUTURE. THERE WERE NO PLANS FOR REVISION AS OF THE DAY OF THE REPORT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD A ¿TUMBLING FALL¿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

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION REPORTED THAT THE LAST REPROGRAMMING RESOLVED THE ISSUE. THE PATIENT HAD NO COMPLAINTS ABOUT HER THERAPY AND DECLINED THE NEED FOR REPROGRAMMING. IT WAS NOTED THAT ONLY A POCKET REVISION WAS DONE. THE PADDLE LEAD WAS FRACTURED. NOTHING WAS DONE WITH IT AND THE PATIENT¿S EXISTING PROGRAMS WERE WORKING FOR HER AT THE DATE OF REPORT.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION REPORTED THAT A POCKET REVISION WAS PLANNED FOR (B)(6) 2013 AT (B)(6)CENTER WITH DR. (B)(6). ADDITIONAL INFORMATION REPORTED THAT A SUCCESSFUL REVISION OF DEVICE POCKET OCCURRED AT THE DATE OF REPORT. A COMPLETE FRACTURE OF LEAD WITH ELECTRODES 8-15 AT THE CONNECTOR BLOCK WAS NOTED. THE PATIENT HAD NO COMPLAINTS OF COVERAGE WITH EXISTING LEAD COVERING ALL PAINFUL AREAS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    214745 RESTORE ADVANCED STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37713

    Patients

    Seq Age Sex Outcome Treatment
    1 00060 YR Required Intervention