BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORE ULTRA MRI

    MDR report key: 3961393 · Received July 28, 2014

    Report

    Report Number
    3004209178-2014-13587
    Event Type
    Injury
    Date Received
    July 28, 2014
    Report Date
    July 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
    MO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID 977A275, SERIAL # (B)(4), IMPLANTED: (B)(6) 2014, PRODUCT TYPE LEAD; PRODUCT ID 97740, SERIAL # (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT; PRODUCT ID 97754, SERIAL # (B)(4), PRODUCT TYPE RECHARGER; PRODUCT ID 3550-29, LOT # N383434, IMPLANTED: (B)(6) 2014, PRODUCT TYPE ACCESSORY; PRODUCT ID 97740, SERIAL # (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT; PRODUCT ID NEU_PTM_PROG, SERIAL # UNKNOWN, PRODUCT TYPE PROGRAMMER, PATIENT; PRODUCT ID A03888001, SERIAL # UNKNOWN, PRODUCT TYPE RECHARGER; PRODUCT ID 97754, SERIAL # (B)(4), PRODUCT TYPE RECHARGER. (B)(4).

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCT: PRODUCT ID 977A275, SERIAL # (B)(4), IMPLANTED: (B)(6) 2014, PRODUCT TYPE LEAD; PRODUCT ID 97740, SERIAL # (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT; PRODUCT ID 97754, SERIAL # (B)(4), PRODUCT TYPE RECHARGER; PRODUCT ID 3550-29, LOT # N383434, IMPLANTED: (B)(6) 2014, PRODUCT TYPE ACCESSORY; PRODUCT ID 97740, SERIAL # (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT; PRODUCT ID NEU_PTM_PROG, PRODUCT TYPE PROGRAMMER, PATIENT. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT WAS CONFUSING THE COUPLING BARS WITH THE INS CHARGE LEVEL. THE IMPLANTABLE NEUROSTIMULATOR (INS) WAS ¿FULLY CHARGED THIS PAST FRIDAY, BUT IT¿S NOT KEEPING ITS CHARGED AT ALL.¿ THE PATIENT WAS NOT ABLE TO USE THE STIMULATION BECAUSE IT HAD BEEN OFF SINCE MONDAY, ¿IT GOES COMPLETELY OFF AND YOU DON¿T FEEL ANYTHING.¿ THE PATIENT CHARGED HER IMPLANT LAST FRIDAY BUT NOW IT HAD NO CHARGE. THE PATIENT REPORTEDLY SAW A LIGHTNING BOLT AND ALL THE BOXES WERE FILLED. IT WAS REPORTED THE PATIENT NOTED THAT THEY HAVE ¿REDONE THE STIMULATOR 3 TIMES AND MY BATTERY ONCE SINCE THEY PUT THE 2ND BATTERY IN IT¿S JUST NOT BEEN WORKING RIGHT.¿ ADDITIONAL INFORMATION RECEIVED REPORTED THERE WAS A COUPLING PROBLEM. THE PATIENT LAST CHARGED LAST FRIDAY AND JUST RECEIVED HER REPLACEMENT PROGRAMMER. IT WAS NOTED IT WAS NOT WORKING WITH HER IMPLANT. THE PATIENT ONLY GOT 2 BOXES SHADED EVEN AFTER USING THE AL FEATURE. THE INS BATTERY WAS ONLY HALF FULL. REFERENCE MFR REPORT # 3004209178-2014-11965 FOR PATIENT'S PREVIOUS BATTERY REVISION.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT THERE WAS A PROBLEM WITH THE PATIENT PROGRAMMER AND THE PATIENT ALL THE PATIENT SAW WAS THE PATIENT PROGRAMMER LIGHT UP AND SHOW MEDTRONIC. WHEN THE PATIENT PUSHED THE SYNCH KEY THEY REPORTEDLY GOT A COMMUNICATION ERROR. IT WAS NOTED THAT THIS WAS DIFFERENT THAN WHAT THE PATIENT WAS REPORTING AND THEY GOT THE COMMUNICATION ERROR BECAUSE THEY DID NOT HAVE IT OVER THE IMPLANT. THE PATIENT PROGRAMMER HAD REPORTEDLY BEEN REPLACED IN EARLY JULY PRIOR TO THE REPORT. IT WAS FURTHER REPORTED THAT THERE WAS A COUPLING PROBLEM. THE PATIENT WOULD REPORTEDLY GET COUPLING RIGHT AWAY AND THEN LOSE THEM; HOWEVER, WHEN THE PATIENT TRIED AT THE TIME OF THE REPORT THEY GOT COUPLING AND WERE ABLE TO MAINTAIN THEM. IT WAS NOTED THAT THE EQUIPMENT WAS WORKING NORMALLY AT THE TIME OF THE REPORT. IT WAS LATER REPORTED THERE WAS A COUPLING PROBLEM. THE PATIENT REPORTEDLY RECEIVED A NEW ANTENNA BUT THEY WERE STILL HAVING COUPLING ISSUES WITH THE IMPLANTABLE NEUROSTIMULATOR (INS). IT WAS NOTED THAT THE INS WAS SITTING AT AN ANGLE IN THE POCKET. THE PATIENT REPORTEDLY RECEIVED A REPLACEMENT PROGRAMMER ABOUT 3 WEEKS PRIOR TO THE REPORT AND THEY WERE SEEING THE SPLASH SCREEN. IT WAS VERIFIED THAT THE PATIENT WAS USING AAA BATTERIES AND THEY REPORTEDLY HAD BOUGHT NEW BATTERIES THAT MORNING. IT WAS NOTED THAT THE PATIENT WAS ALSO SENT A NEW ANTENNA AND THEIR COUPLING WAS STILL NOT CONSISTENT. THE PATIENT WAS REPORTEDLY ABLE TO MAINTAIN COUPLING AT THE TIME OF THE REPORT BUT THE PATIENT NOTED THAT IT COMES AND GOES OFTEN. THE PATIENT REPORTEDLY COULD FEEL THEIR IMPLANTABLE NEUROSTIMULATOR (INS) SITTING AT AN ANGLE.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THE PATIENT AS UNABLE TO ADJUST STIMULATION. A PROBLEM WITH THE PATIENT PROGRAMMER (PP) WAS REPORTED. A COUPLING PROBLEM WAS REPORTED. THE PATIENT TRIED TO RECHARGE AGAIN LAST NIGHT AND HAD 8 BARS, BUT THAT CHANGED TO 2 BARS THE MORNING OF THIS REPORT. IT WAS REPORTED ¿IT¿ KEPT ON BLINKING AND BEEPING. IT WAS NOTED THE PATIENT COULD BARELY FEEL THE INS, IT FELT LIKE A LUMP. THE PATIENT REPORTEDLY HAD THE ISSUE SINCE SHE RECEIVED THE IMPLANT. THE PATIENT WAS REPORTEDLY SCHEDULED TO HAVE A REVISION TO THE WIRE ON (B)(6) BUT DID NOT TELL THE HCP ABOUT ANY ISSUES TO THE POCKET SITE. THE PATIENT WAS GOING TO CALL FOR A POCKET ASSESSMENT. ADDITIONAL INFORMATION RECEIVED REPORTED THE PATIENT HAD DIFFICULTY RECHARGING, HAD COUPLING ISSUES AND THE BARS CONSTANTLY CHANGED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    437752 RESTORE ULTRA MRI STIMULATOR, SPINAL-CORD, IMPLANTED (PAIN RELIEF) LGW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 97712

    Patients

    Seq Age Sex Outcome Treatment
    1 00049 YR Required Intervention