BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE

    MDR report key: 4412136 · Received January 13, 2015

    Report

    Report Number
    3004209178-2015-00585
    Event Type
    Malfunction
    Date Received
    January 13, 2015
    Report Date
    December 16, 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
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 377760, LOT# V012405, IMPLANTED: (B)(6) 2006, PRODUCT TYPE: LEAD; PRODUCT ID 377760, LOT# V012405, IMPLANTED: (B)(6) 2006, PRODUCT TYPE: LEAD; PRODUCT ID 37742, SERIAL# (B)(4), PRODUCT TYPE: PROGRAMMER, PATIENT. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THE CORNER OF THE PATIENT¿S IMPLANTABLE NEUROSTIMULATOR (INS) WAS CRACKED AND CAUSING A LOT OF BACK PAIN. THE PATIENT STATED THEY WERE TOLD THE INS WOULD NOT SHOW THROUGH THE SKIN, BUT IT HAD BEEN GRADUALLY GETTING WORSE. THE PATIENT¿S FATHER HAD FELT THE EDGE OF IT. THE PATIENT FOUND THE INS WAS CRACKED THE DAY PRIOR TO THIS REPORT BECAUSE THEY COULD FEEL IT. SINCE 2006, THE INS HAD BEEN TOLERABLE TO LIVE WITH, BUT NOW IT WAS SHOWING THROUGH THEIR SKIN. A WEEK PRIOR TO THIS REPORT THE PATIENT WENT TO THE EMERGENCY ROOM BECAUSE IT HURT SO BAD. THE EMERGENCY ROOM HEALTHCARE PROFESSIONALS (HCP) TOLD THEM THAT THEY WOULD HAVE TO TAKE THE RIGHT INS OUT AND IMPLANT ONE DEEPER IN THEIR LEFT SIDE. AN X-RAY AND CT SCAN WERE DONE. THE PATIENT WAS GOING IN FOR HERNIA SURGERY FOR THE LEFT SIDE OF THEIR STOMACH NEXT MONTH AND THEY WERE GOING TO OPEN THEM UP THROUGH THE STOMACH. 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.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    31151 RESTORE STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37711

    Patients

    Seq Age Sex Outcome Treatment
    1