BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORE SENSOR

    MDR report key: 4243544 · Received November 11, 2014

    Report

    Report Number
    3004209178-2014-21319
    Event Type
    Injury
    Date Received
    November 11, 2014
    Date of Event
    March 29, 2013
    Report Date
    November 3, 2014
    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
    KY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID 37744, SERIAL # (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT; PRODUCT ID 39565-65, SERIAL # (B)(4), IMPLANTED: (B)(6) 2012, PRODUCT TYPE LEAD. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE IMPLANTABLE NEUROSTIMULATOR (INS) WAS REPOSITIONED TO PUT THE PATIENT¿S PAIN PUMP IN. DURING THE PROCEDURE THE LEAD WIRING WAS ¿RECONSTRUCTED¿ BECAUSE A LEAD HAD ¿BUSTED.¿ THE LEAD HAD GOTTEN STUCK AND SOME OF THE PATIENT¿S BONE HAD TO BE GROUND DOWN IN ORDER TO GET THE LEAD WIRES TO COME OUT. THE LEAD WIRES WERE ¿REROUTED.¿ NO OUTCOME WAS REPORTED REGARDING THIS EVENT. FURTHER FOLLOW-UP IS BEING CONDUCTED TO OBTAIN THIS INFORMATION. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW-UP REPORT WILL BE SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    727440 RESTORE SENSOR STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37714

    Patients

    Seq Age Sex Outcome Treatment
    1 00048 YR Required Intervention