BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PRIMEADVANCED

    MDR report key: 2495396 · Received March 19, 2012

    Report

    Report Number
    3004209178-2012-01665
    Event Type
    Malfunction
    Date Received
    March 19, 2012
    Date of Event
    February 18, 2012
    Report Date
    February 21, 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
    MI, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    LEAD: MODEL 3998, LOT# V279273, IMPLANTED: (B)(6) 2009, EXPLANTED: NA; ANCHOR: MODEL 3550-39, LOT# N230568, IMPLANTED: (B)(6) 2009, EXPLANTED: NA; EXTENSION: MODEL 3708140, SERIAL# (B)(4), IMPLANTED: (B)(6) 2009, EXPLANTED: NA; EXTENSION: MODEL 3708140, SERIAL# (B)(4), IMPLANTED: (B)(6)2009, EXPLANTED: NA; EXTENSION: MODEL 3708220, SERIAL# (B)(4), IMPLANTED: (B)(6) 2009, EXPLANTED: NA; PROGRAMMER: MODEL 37743, SERIAL# (B)(4).

    Additional Manufacturer Narrative · 1

    ANALYSIS OF THE IMPLANTABLE NEUROSTIMULATOR FOUND THE BATTERY WAS AT NORMAL END OF LIFE AND TELEMETRY AND OUTPUT WERE OKAY.

    Additional Manufacturer Narrative · 1

    ANALYSIS RESULTS WERE NOT AVAILABLE AT THE TIME OF THIS REPORT. A FOLLOW-UP REPORT WILL BE SENT WHEN ANALYSIS IS COMPLETED. (B)(4).

    Additional Manufacturer Narrative · 1

    ANALYSIS OF THE IMPLANTABLE NEUROSTIMULATOR FOUND NO SIGNIFICANT ANOMALY. IT WAS NOTED THE BATTERY WAS AT NORMAL END OF LIFE AND TELEMETRY AND OUTPUT WERE OKAY.

    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 REPORTED INDICATED THAT AFTER REPROGRAMMING THE PATIENT HAD FULL COVERAGE EQUALLY AND BILATERALLY IN THE BACK AND LEGS. IMPEDANCE TESTS REVEALED NO OPEN OR CLOSED CIRCUITS. IMPEDANCES WERE NORMAL. NO OTHER DIAGNOSTICS WERE PERFORMED. NO SURGICAL INTERVENTIONS WERE NEEDED. THE REPROGRAMMING GAVE DESIRED THERAPEUTIC EFFECT. THE PATIENT WAS HAPPY WITH THE CHANGES MADE TO HER PROGRAMS. MORE THAN ONE AND A HALF YEARS LATER IT WAS REPORTED THAT THERE WAS A NORMAL BATTERY DEPLETION SO THE INS WAS EXPLANTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT EXPERIENCED NO STIMULATION SENSATION AND A LOSS OF THERAPEUTIC EFFECT IN THE RIGHT ARM AND HAND. IN ADDITION, THE PATIENT'S RIGHT EYE WAS SWOLLEN. THE PATIENT HAD TRIED TO REPROGRAM HERSELF WITHOUT SUCCESS, AND HAD INCREASED STIMULATION TO 10.0 VOLTS. ADDITIONAL INFORMATION HAS BEEN 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 00073 YR