BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORE ULTRA

    MDR report key: 3840566 · Received May 30, 2014

    Report

    Report Number
    3004209178-2014-09879
    Event Type
    Injury
    Date Received
    May 30, 2014
    Report Date
    May 2, 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
    OK, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID 37752, SERIAL# (B)(4); PRODUCT TYPE RECHARGER PRODUCT ID 37743, SERIAL# (B)(4); PRODUCT TYPE PROGRAMMER, PATIENT PRODUCT ID 3778-60, SERIAL# (B)(4), IMPLANTED: 2011 (B)(6); PRODUCT TYPE LEAD. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT¿S IMPLANTABLE NEUROSTIMULATOR (INS) NEEDED TO BE REPOCKETED. IT WAS STATED THAT THE PATIENT HAD A ¿GROWTH¿ THAT FELT LIKE IT WAS ¿ON THE INS UNDER THE SKIN¿. IT WAS STATED THAT THIS GROWTH HAS BEEN THERE FOR ABOUT 1 YEAR. IT WAS REPORTED THAT IT WOULD HURT REAL BAD AROUND THE INS, AND SOMETIMES BROUGHT THE PATIENT TO TEARS. IT WAS STATED THAT IT FELT LIKE SOMETHING WAS PULLING AND RIPPING AT THE SKIN. IT WAS NOTED THAT BOTH THE HEALTHCARE PROFESSIONAL (HCP) AND MANUFACTURER¿S REPRESENTATIVE LOOKED AT IT 6-8 MONTHS AGO. IT WAS STATED THAT THE HCP ¿DETERMINED THE PATIENT WOULD NEED TO HAVE THE DEVICE REPOCKETED¿ BUT THE MANUFACTURER¿S REPRESENTATIVE SAID ¿EVERYTHING LOOKED FINE¿. IT WAS STATED THAT THE PATIENT ¿WASN¿T SURE IF IT¿S A SCREW, BONE OR WHAT IT IS¿. IT WAS NOTED THAT THE PATIENT HAS ¿LOST SOME WEIGHT¿. THE PATIENT INQUIRED WHETHER THE MANUFACTURER¿S REPRESENTATIVE NEEDED TO GET INVOLVED WITH THE HCP TO HAVE IT REPOCKETED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE PATIENT NEEDED HER IMPLANTABLE NEUROSTIMULATOR (INS) TAKEN OUT BUT DOESN¿T TRUST THE DOCTOR SHE HAD BEFORE. SHE FELT THAT THE HEALTHCARE PROVIDER (HCP) WOULD INTENTIONALLY HURT THE PATIENT. THE PATIENT STATED SHE TOLD THE HCP FOR THE LAST TWO YEARS IT WASN¿T WORKING, AND THEY WORKED ON IT AND WORKED ON IT. SHE HAD MET WITH THE MANUFACTURER¿S REPRESENTATIVES (REPS) WHO WOULD DO PROGRAMMING. IT WAS NOTED SHE HAD SEEN THE REP. THREE TO FOUR TIMES OVER THE LAST FEW YEARS. IT WAS NOTED THE INS WORKED FINE FOR THE FIRST COUPLE OF YEARS BUT THEN IT STARTED HURTING. THE PATIENT THOUGHT WHERE THE INS WAS PLACED FELT LIKE THE SKIN ALL THE WAY AROUND IT WAS RIPPING AND SHE COULDN¿T STAND IT. THIS STARTED A COUPLE OF YEARS AGO WITH A SUDDEN ONSET. IT WAS NOTED THE PATIENT FELL A LOT PRIOR TO IMPLANT BECAUSE OF A CAR ACCIDENT SIX YEARS AGO. SHE DIDN¿T HAVE GOOD BALANCE AND FELL A LOT BECAUSE HER LEFT LEG DIDN¿T PICK UP ALL OF THE TIME. WHEN THE PATIENT WAS ASKED IF SHE RECALLED AROUND THE TIME THIS STARTED HURTING IF SHE FELL SHE STATED SHE DIDN¿T THINK SHE FELL, IT JUST SEEMED TO COME ON ALL OF A SUDDEN FOR NO REASON. IT WAS NOTED THE HCP TOLD THE PATIENT SHE WOULD TAKE OUT THE INS BUT NEVER DID. THE PATIENT STATED THE HCP THOUGHT MAYBE BECAUSE THE PATIENT LOST SOME WEIGHT THE INS WAS POSSIBLY MOVING AROUND. THE PATIENT STATED IT WAS HURTING BEFORE THAT AND DIDN¿T BELIEVE THAT WAS THE TRUTH AND STATED IT ALSO HAD A ¿KNOT ON THERE,¿ AND THE HCP TOLD THE PATIENT THAT WAS LIKE A SCREW OR SOMETHING OR WHERE THE BONE HAD GROWN OVER IT. 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
    318848 RESTORE ULTRA STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37712

    Patients

    Seq Age Sex Outcome Treatment
    1 00046 YR Required Intervention