BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PRIMEADVANCED

    MDR report key: 3067997 · Received April 19, 2013

    Report

    Report Number
    3004209178-2013-06572
    Event Type
    Malfunction
    Date Received
    April 19, 2013
    Report Date
    April 5, 2013
    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
    IN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID 37746, SERIAL# (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT; PRODUCT ID 3708240, SERIAL# (B)(4), IMPLANTED: (B)(6) 2006, PRODUCT TYPE EXTENSION; PRODUCT ID 3998, LOT# V011552, IMPLANTED: (B)(6) 2006, PRODUCT TYPE LEAD; PRODUCT ID 3708240, SERIAL# (B)(4), IMPLANTED: (B)(6) 2006, PRODUCT TYPE EXTENSION; PRODUCT ID 3998, LOT# V011552, IMPLANTED: (B)(6) 2006, PRODUCT TYPE LEAD. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION STATED THE PATIENT STILL HAD CONCERNS WITH HER DEVICE OR THERAPY. IT WAS STATED ¿IT DID NOT WORK¿ AND THAT ¿IT STOPPED WORKING TWO MONTHS AFTER INSTALLED.¿ IT WAS ALSO NOTED THE PATIENT WAS IN TEXAS AT THE TIME OF REPORT AND PLANNED TO CALL HER DOCTOR WHEN SHE RETURNED TO INDIANA.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT NEVER HAD THERAPEUTIC EFFECT. THE REPORTER STATED THAT THE DEVICE NO LONGER WORKED AND THAT THE DEVICE USED TO 'SHOCK' THE PATIENT'S LEGS BUT NOW 'DIDN'T DO ANYTHING.' IT WAS REPORTED THAT THE PATIENT COULD INCREASE THE SETTINGS OF THE DEVICE BUT DIDN'T FEEL ANYTHING. THE REPORTER STATED THAT THE DEVICE HAD WORKED ON AND OFF SINCE IMPLANT. IT WAS REPORTED THAT THIS STARTED ABOUT 1.5 MONTHS AGO, AND THERE WAS NO KNOWN ACCIDENT OR INCIDENT RELATED TO THE COMPLAINT. THE REPORTER STATED THAT THE DEVICE HAD BEEN PROGRAMMED BUT IT DID NOT HELP. IT WAS REPORTED THAT THE PATIENT HAD NOT RETURNED TO THE HEALTHCARE PROVIDER'S OFFICE. IT WAS NOTED THAT THE PATIENT PLANNED TO SEE HER HEALTHCARE PROVIDER AT THE END OF THE MONTH. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.

    Description of Event or Problem · 1

    IT WAS NOTED THAT THE PATIENT NEVER HAD A PROBLEM WITH THE "OLD" UNIT THAT WAS IMPLANTED PREVIOUSLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    169873 PRIMEADVANCED STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37702

    Patients

    Seq Age Sex Outcome Treatment
    1