BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PRIMEADVANCED

    MDR report key: 3033840 · Received April 3, 2013

    Report

    Report Number
    3004209178-2013-04589
    Event Type
    Malfunction
    Date Received
    April 3, 2013
    Report Date
    March 14, 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
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID 39286-65, SERIAL# (B)(4), IMPLANTED: (B)(6) 2010, PRODUCT TYPE: LEAD. PRODUCT ID 3550-39, LOT# N269611, IMPLANTED: (B)(6) 2010, PRODUCT TYPE: ACCESSORY. PRODUCT ID 37743, SERIAL# (B)(4), PRODUCT TYPE: PROGRAMMER, PATIENT. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT FELL ON HER LEFT SIDE SIX MONTHS PRIOR TO REPORT AND THE PATIENT'S DEVICE WAS IMPLANTED IN THE LEFT UPPER BUTTOCK. SINCE THE FALL, IT WAS REPORTED THE PATIENT'S PAIN INCREASED AND THE STIMULATION WAS "WORKING LESS AND COVERING LESS AREA". THE PATIENT STATED THE DEVICE AREA WAS PAINFUL TO THE TOUCH AND THE PAIN RADIATED DOWN HER LEG, "TAKING AWAY HER MOBILITY". IT WAS REPORTED THE PATIENT'S PAIN WAS DESCRIBED AS A BURNING SENSATION. IT WAS ALSO STATED THE PATIENT HAD DIFFICULTY TURNING THE STIMULATION OFF WITH THEIR PROGRAMMER. THE PATIENT REPORTEDLY HAD CORTISONE SHOTS IN HER HEAL TO HELP WITH THE PAIN BUT IT DID NOT HELP WITH MOBILITY. THE PATIENT ALSO REPORTED A LOSS OF THERAPEUTIC EFFECT. LATER THAT DAY, IT WAS REPORTED THE PATIENT COULD NOT TURN THE STIMULATION OFF AND REPEATEDLY SAW A POOR COMMUNICATION SCREEN ON THE PROGRAMMER. THE PATIENT REPORTEDLY TOOK THE BATTERIES OUT OF THE PROGRAMMER AND STATED THE STIMULATION WAS STILL ON. WITH TROUBLESHOOTING ASSISTANCE, THE PATIENT WAS THEN ABLE TO TURN THE STIMULATION OFF BY PLACING THE PROGRAMMER OVER HER IMPLANTED DEVICE. ADDITIONAL INFORMATION HAS BEEN REQUESTED. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION REPORTED, THE PATIENT HAD SORENESS IN THE IMPLANTABLE NEUROSTIMULATOR (INS) POCKET SITE. IT WAS STATED THE PATIENT COULD NOT EVEN WALK CORRECTLY. IT WAS NOTED, THE PATIENT COULD NOT TURN THE STIMULATION OFF.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    136216 PRIMEADVANCED STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37702

    Patients

    Seq Age Sex Outcome Treatment
    1 00063 YR