BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORE

    MDR report key: 2559013 · Received May 3, 2012

    Report

    Report Number
    3004209178-2012-02967
    Event Type
    Injury
    Date Received
    May 3, 2012
    Report Date
    April 9, 2012
    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
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID 399930, LOT # V010129, IMPLANTED: (B)(6) 2006, EXPLANTED: NA, PRODUCT TYPE LEAD. PRODUCT ID 3708240, SERIAL # (B)(4), IMPLANTED: (B)(6) 2006, EXPLANTED: NA, PRODUCT TYPE EXTENSION. PRODUCT ID 37752, SERIAL # (B)(4), PRODUCT TYPE RECHARGER. PRODUCT ID 37742, SERIAL # (B)(4), PRODUCT TYPE PROGRAMMER.

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT EXPERIENCED A LOSS OF THERAPEUTIC EFFECT FIVE DAYS AGO. THERE WAS NO KNOWN ACCIDENT OR EVENT RELATED TO THE LOSS OF STIMULATION. THE IMPLANTABLE NEUROSTIMULATOR (INS) WAS CONFIRMED TO BE ON, AND INCREASING THE AMPLITUDE IN EITHER OF THE PATIENT'S PROGRAMS HAD NO EFFECT. THE INS BATTERY LEVEL WAS AT 75%. ADDITIONAL INFORMATION WAS REQUESTED, BUT WAS NOT AVAILABLE AT THE TIME OF THIS REPORT.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION INDICATED THE CAUSE OF THE EVENT WAS UNKNOWN. IMPEDANCES ON ALL ELECTRODES WERE REPORTED TO BE LESS THAN 3600 OHMS. RESULTS FROM X-RAY ON (B)(6) WERE DOCUMENTED AS "VISUALLY ALL PIECES, NO APPARENT BREAK." NORMAL BATTERY DEPLETION WAS NOTED ON THE IMPLANTABLE NEUROSTIMULATOR (INS). THE INS, LEAD, AND EXTENSION WERE REPLACED. THE LEAD WAS CHECKED BEFORE THE REPLACEMENT, ALL IMPEDANCES WERE GREATER THAN 1000 OHMS. WHEN THE NEW LEAD WAS CONNECTED TO THE EXISTING EXTENSION AND THE INS, BAD IMPEDANCES WERE SHOWN AGAIN. WHEN BOTH THE EXTENSION AND THE INS WERE REPLACED, ALL IMPEDANCES WERE WITHIN NORMAL LIMITS. PARESTHESIA WAS REPORTED TO BE "IN RECOVERY." THE PATIENT DID NOT REQUIRE HOSPITALIZATION AND THE PATIENT OUTCOME WAS REPORTED AS RECOVERED WITHOUT SEQUELAE. THERE WERE NO PATIENT SYMPTOMS RELATED TO THIS EVENT. PATIENT STATUS AT TIME OF THIS REPORT WAS NOTED AS ALIVE WITH NO INJURY/NO ADVERSE EVENT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 00052 YR Required Intervention