BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE

    MDR report key: 4031669 · Received August 22, 2014

    Report

    Report Number
    3004209178-2014-15788
    Event Type
    Malfunction
    Date Received
    August 22, 2014
    Report Date
    August 1, 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
    WA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 37742, SERIAL# (B)(4), PRODUCT TYPE: PROGRAMMER, PATIENT; PRODUCT ID 3 7752, SERIAL# (B)(4), IMPLANTED: (B)(6) 2006, PRODUCT TYPE: RECHARGER; PRODUCT ID 3708160, SERIAL# (B)(4), IMPLANTED: (B)(6) 2006, PRODUCT TYPE: EXTENSION; PRODUCT ID 355029, LOT# N060883, IMPLANTED: (B)(6) 2006, PRODUCT TYPE: ACCESSORY; PRODUCT ID 377845, LOT# V004106, IMPLANTED: (B)(6) 2006, PRODUCT TYPE: LEAD; PRODUCT ID 377845, LOT# V004106, IMPLANTED: (B)(6) 2006, PRODUCT TYPE: LEAD. (B)(4).

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED FROM THE CONSUMER REPORTED THAT THE PATIENT WAS EXERCISING ONE DAY WHEN THEY RECEIVED AN ELECTRICAL SHOCK THAT TOOK THE PATIENT DOWN TO THEIR KNEES. THE PATIENT HAD BEEN FEARFUL OF IMPLANT SINCE THEN. THE PATIENT WAS UNDER THE IMPRESSION THAT THE IMPLANT WAS NO LONGER WORKING FOR THE PATIENT. THE PATIENT WAS INDICATED FOR DEGENERATIVE DISC DISEASE. NO INTERVENTIONS OR OUTCOME WERE 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT WAS EXPERIENCING A SHOCKING SENSATION. THE PATIENT HAD TWO EPISODES WHEN THEY FELT A SHOCKING SENSATION STARTING THE FIRST PART OF THE WEEK OF THIS REPORT. THE REPORTER STATED THE PATIENT WAS TRYING TO WALK WHEN THEY FELT A SHOCK. THE PATIENT HAD BROKEN THEIR HIP TWICE, THREE YEARS AGO AND ONCE YEAR AGO. AN X-RAY HAD BEEN DONE AND THE PATIENT¿S LEAD WAS FRACTURED. THE LOCATION OF THE LEAD FRACTURE WAS UNKNOWN, BUT THE PATIENT¿S HEALTHCARE PROFESSIONAL BELIEVED IT MAY HAVE OCCURRED AT THE TIME OF THE PATIENT¿S FALL ONE YEAR AGO. DUE TO THE PATIENT¿S AGE AND HEALTH A DECISION HAD NOT BEEN MADE ABOUT A LEAD REPLACEMENT. THE PATIENT WAS INSTRUCTED TO STOP CHARGING THEIR DEVICE AND THE IMPLANTABLE NEUROSTIMULATOR (INS) WAS PROGRAMMED TO OFF. THE PATIENT¿S PAIN WAS BEING CONTROLLED WITH ORAL MEDICATIONS. 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
    508785 RESTORE STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37711

    Patients

    Seq Age Sex Outcome Treatment
    1 00093 YR