BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PRIMEADVANCED

    MDR report key: 2677347 · Received August 1, 2012

    Report

    Report Number
    3004209178-2012-06323
    Event Type
    Malfunction
    Date Received
    August 1, 2012
    Report Date
    July 6, 2012
    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
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID 399945, LOT# V033961, IMPLANTED: (B)(6) 2007, PRODUCT TYPE LEAD; PRODUCT ID 377660, LOT# V013772, IMPLANTED: (B)(6) 2007, PRODUCT TYPE LEAD; PRODUCT ID 37742, SERIAL# (B)(4), IMPLANTED: (B)(6) 2007, PRODUCT TYPE PROGRAMMER, PATIENT; 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 THE PATIENT EXPERIENCED A "SHOCKING AND OVERSTIMULATION SENSATION," AS WELL AS A LOSS OF THERAPEUTIC EFFECT. THE PATIENT STATED THAT HE HAD A TRIAL PROCEDURE AND IT "WORKED SOMEWHAT." THE PATIENT ALSO STATED THAT "HE THOUGHT THE ARTHRITIS IN HIS BODY WAS TAKING OVER." THE PATIENT FURTHER NOTED THAT IT WAS "BETTER TO HAVE THE STIMULATION TURNED OFF" AND THAT "IT IRRITATED HIM AT NIGHT WHEN HE LAID DOWN." THE PATIENT FELT THAT "HE WAS IN SO MUCH PAIN THAT HIS EARS WOULD RING." THE PATIENT HAD BEEN REPROGRAMMED MANY TIMES, THE LAST BEING ABOUT A MONTH OR TWO AGO. THE PATIENT STATED THAT HE DID NOT USE THE STIMULATION VERY OFTEN AND THAT PHYSICAL AND WATER THERAPY HAD HELPED EASE THE STIFFNESS, BUT NOT THE PAIN. IT WAS NOTED THAT WHEN THE STIMULATOR CAME ON, THE STIMULATION WAS TOO STRONG AND IT "JUST ABOUT SHOOK HIM TO DEATH." THE PATIENT STATED THAT IT DID NOT HELP WHEN THE SETTINGS WERE LOW, BUT IT WOULD HURT IF THE STIMULATION WAS TOO HIGH. IT WAS NOTED THAT THE PATIENT HAD AN X-RAY PERFORMED BY A JOINT SPECIALIST, WHO "DID NOT FIND ANYTHING WRONG." THE PATIENT HAD ANOTHER SCHEDULED APPOINTMENT WITH THE PHYSICIAN. THE PATIENT OUTCOME WAS NOT PROVIDED. ADDITIONAL INFORMATION WAS REQUESTED, BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.

    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