BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRIMEADVANCED

    MDR report key: 2834194 · Received November 15, 2012

    Report

    Report Number
    3004209178-2012-10327
    Event Type
    Injury
    Date Received
    November 15, 2012
    Date of Event
    October 11, 2012
    Report Date
    February 2, 2018
    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
    WI, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID: 39565-65, SERIAL#: (B)(4), IMPLANTED: (B)(6) 2010, PRODUCT TYPE: LEAD; PRODUCT ID: 37742, SERIAL#: (B)(4), PRODUCT TYPE: PROGRAMMER, PATIENT. (B)(4).

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT A PATIENT'S HEALTH CARE PROVIDER HAD NO KNOWLEDGE ABOUT ANY SHOCKING, JOLTING, OR PAIN RUNNING DOWN THE LEGS. THE REPORTER STATED THAT BEFORE MOVING TO A NEW STATE, THE PATIENT HAD HER DEVICE INTERROGATED AND WAS TOLD THAT AS LONG AS THE SETTINGS WERE NOT CHANGED, SHE HAD 40 MONTHS LEFT BEFORE SHE WOULD NEED A REPLACEMENT. IT WAS REPORTED THAT THE DEVICE HAD NOT WORKED SINCE (B)(6) 2012. IT WAS UNCLEAR WHEN THE DEVICE LAST WORKED. IT WAS NOTED THAT THE PATIENT WAS ON A PAIN MEDICATION CONTRACT, BUT SINCE THE DEVICE WASN'T WORKING THE PATIENT HAD BEEN TAKING MORPHINE AGAIN. THE REPORTER STATED THAT THE PATIENT DIDN'T HAVE INSURANCE, WAS AWAITING DISABILITY, AND THERE WAS "NOTHING THEY COULD DO" UNTIL SHE HAD NEW INSURANCE AND THEY COULD REPLACE THE DEVICE. A FOLLOW-UP REPORT WILL BE MADE IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT IN (B)(6) 2011, THE PATIENT HAD HER BATTERY CHECKED AND WAS TOLD SHE HAD "UP TO FOUR YEARS TO GO". THE PATIENT STATED SHE HAS NOT CHANGED THE SETTINGS SINCE THEN AND THE DAY PRIOR TO REPORT SHE CHECKED HER DEVICE AND IT DISPLAYED END OF SERVICE (EOS). IT WAS ALSO REPORTED THAT THE PATIENT HAD A "MINI SHOCK OR JOLTING". THE PATIENT'S LEGS WERE BOTHERING HER THAT MORNING AND SHE TOOK MORPHINE THREE TIMES A DAY. THE PATIENT STATED SHE HAD A "DISC BLOWN" IN HER BACK AND HAD SURGERY ON IT. A CONJOINED NERVE ROOT WAS FOUND AND SCAR TISSUE FORMED THERE AND HAD PAIN DOWN HER LEFT LEG AND BACK. THE PATIENT STATED IT WAS LIKE "BURNING AND AN ELECTRICAL CHARGE DOWN HER LEFT LEG". ON (B)(6) 2012 IT WAS REPORTED THAT THE PATIENT HAD BEEN INFORMED THAT WITH A PRIME BATTERY NO GUARANTEE FOR LONGEVITY COULD BE ESTIMATED OR DETERMINED. THE PATIENT WAS TOLD THAT AT 24 MONTHS HER BATTERY WOULD HAVE BEEN CONSIDERED NORMAL BATTERY DEPLETION, BUT SHE "CLEARLY" STATED THAT HER BATTER EXPIRED "A WHILE AGO". ADDITIONAL INFORMATION RECEIVED ON (B)(4) 2012 REPORTED THAT THE DEVICE STOPPED WORKING ON (B)(6) 2012. THE PATIENT WAS UNABLE TO ADJUST HER STIMULATION AND SAW A "CALL YOUR DOCTOR" ICON ALONG WITH THE EOS MESSAGE.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION: IT WAS REPORTED THAT A PATIENT¿S BACK HAS GOTTEN WORSE, SEVERELY WORST. THE PATIENT ALSO MENTIONED THAT SHE CANNOT LAY ON HER SIDE WHERE THE BATTERY IS IMPLANTED. THE PATIENT ALSO STATED THAT SHE WANTS TO GET THIS DEVICE REMOVED BADLY. THE PATIENT ALSO STATED SHE HAS BEEN DIAGNOSED WITH ARACHNOIDITIS. PATIENT SERVICES SENT OUT PHYSICIAN LISTINGS SO THE PATIENT CAN ARRANGE THIS. NO FURTHER INFORMATION WAS REPORTED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED FROM A MANUFACTURER'S REPRESENTATIVE (REP). IT WAS REPORTED THAT THE HEALTHCARE PROVIDER (HCP) WAS GOING TO REMOVE THE SYSTEM FOR ISSUES REPORTED PREVIOUSLY. NO NEW EVENT INFORMATION AVAILABLE EXCEPT THAT THE SYSTEM WILL BE REMOVED. NO FURTHER COMPLICATIONS WERE REPORTED OR ANTICIPATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PRIMEADVANCED STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37702

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR Other| R