BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE ADVANCED

    MDR report key: 4571106 · Received March 4, 2015

    Report

    Report Number
    3004209178-2015-04170
    Event Type
    Malfunction
    Date Received
    March 4, 2015
    Date of Event
    February 6, 2015
    Report Date
    February 13, 2015
    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
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 3487A-45, LOT# V040894, IMPLANTED: (B)(6) 2007, PRODUCT TYPE: LEAD; PRODUCT ID 3487A-45, LOT# V040895, IMPLANTED: (B)(6) 2007, PRODUCT TYPE: LEAD; PRODUCT ID 37752, SERIAL# (B)(4), IMPLANTED: (B)(6) 2007, PRODUCT TYPE: RECHARGER; PRODUCT ID 37742, SERIAL# (B)(4), IMPLANTED: (B)(6) 2007, PRODUCT TYPE: PROGRAMMER, PATIENT; PRODUCT ID 3778-60, SERIAL# (B)(4), IMPLANTED: (B)(6) 2007, PRODUCT TYPE: LEAD; PRODUCT ID 3708220, SERIAL# (B)(4), IMPLANTED: (B)(6) 2007, PRODUCT TYPE: EXTENSION. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A WEEK AGO THE PATIENT WAS HAVING SWELLING AROUND THE ¿IMPACT AREA.¿ THE INCISION AREA WHERE THE IMPLANT WAS LOCATED WAS SWOLLEN AND IT WAS GETTING WORSE, AND IT WAS MOVING TO THE WAIST UP, WRAPPING AROUND THE SIDE. THE PATIENT WAS HAVING A LOT OF PAIN AND THE PAIN WAS GETTING WORSE EVERY DAY. THERE WAS ALSO A BURNING SENSATION ¿BEHIND THE BATTERY PACK,¿ BACK OF THE IMPLANTABLE NEUROSTIMULATOR (INS) INSIDE OF THE BODY, WHICH STARTED 3 DAYS AGO. THEY WERE WONDERING IF THAT WAS CAUSING THE PAIN AND IF THE INS WAS LEAKING INSIDE OF THE BODY. THE PATIENT HAD NOT HAD ANY TRAUMAS. THEY WERE ADVISED TO CONSULT THEIR HEALTHCARE PROVIDER (HCP). 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
    151800 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 00062 YR