BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRIMEADVANCED

    MDR report key: 2991443 · Received March 6, 2013

    Report

    Report Number
    3004209178-2013-03396
    Event Type
    Injury
    Date Received
    March 6, 2013
    Date of Event
    December 26, 2012
    Report Date
    February 19, 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
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID 748940, SERIAL# (B)(4), IMPLANTED: (B)(6) 2005, PRODUCT TYPE: EXTENSION. PRODUCT ID 389033, LOT# J0511425V, IMPLANTED: (B)(6) 2005, PRODUCT TYPE: LEAD. PRODUCT ID 37743, SERIAL# (B)(4), IMPLANTED: (B)(6) 2009, PRODUCT TYPE: PROGRAMMER, PATIENT. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4): FINAL DEVICE ANALYSIS OF THE IMPLANTABLE NEUROSTIMULATOR (INS) REVEALED THE FOLLOWING: NO ANOMALIES FOUND. THE DEVICE FUNCTIONED PROPERLY THROUGHOUT THE DURATION OF THE TEST. THE DEVICE WAS SET TO THE PARAMETERS THE EXPLANTED DEVICE HAD WHEN RECEIVED FOR ANALYSIS. FINAL DEVICE ANALYSIS OF THE LEAD REVEALED THE FOLLOWING: NO SIGNIFICANT ANOMALY FOUND. THE LEAD BODY WAS CUT THROUGH. FINAL DEVICE ANALYSIS OF THE EXTENSION REVEALED THE FOLLOWING: NO SIGNIFICANT ANOMALY FOUND. THE EXTENSION BODY WAS CUT THROUGH. FINAL DEVICE ANALYSIS OF THE PLUG REVEALED THE FOLLOWING: NO ANOMALY FOUND.

    Additional Manufacturer Narrative · 1

    PRODUCT ID 37743, SERIAL# (B)(4), IMPLANTED: (B)(6) 2009, PRODUCT TYPE: PROGRAMMER, PATIENT. PRODUCT ID 389033, LOT# J0511425V, IMPLANTED: (B)(6) 2005, PRODUCT TYPE: LEAD. PRODUCT ID 748940, SERIAL# (B)(4), IMPLANTED: (B)(6) 2005, PRODUCT TYPE: EXTENSION. PRODUCT ID 37082-60, SERIAL# (B)(4), PRODUCT TYPE: EXTENSION. PRODUCT ID 3998, LOT# UNKNOWN, PRODUCT TYPE: LEAD. PRODUCT ID 3550-29, PRODUCT TYPE: ACCESSORY. ANALYSIS RESULTS WERE NOT AVAILABLE AT THE TIME OF THIS REPORT. A FOLLOW-UP REPORT WILL BE SENT WHEN ANALYSIS IS COMPLETED.

    Description of Event or Problem · 1

    IT WAS LATER REPORTED THAT THE PATIENT DISCONTINUED USE OF THE DEVICE FOLLOWING THE SHOCKING SENSATION DURING A MAMMOGRAM BECAUSE HER CHRONIC PAIN HAD SUBSIDED. AT AN APPOINTMENT ON (B)(6) 2013 THE PATIENT REQUESTED TO HAVE THE SYSTEM EXPLANTED BECAUSE SHE NO LONGER USED IT. IT WAS NOTED THAT IMPEDANCE MEASUREMENTS WERE CHECKED AND ALL MEASUREMENTS WERE WITHIN NORMAL LIMITS. WHEN THE PATIENT HAD THE DEVICE REMOVED SHE NOTED THAT SHE FELT IT HAD NOT BEEN FUNCTIONING PROPERLY. IT WAS REPORTED THAT IN ADDITION TO SHOCKING THE PATIENT EXPERIENCED STIMULATION IN THE WRONG LOCATION, LESS THAN 50% PAIN RELIEF, AND A BURNING SENSATION AT THE DEVICE POCKET AND LEAD LOCATION FOLLOWING THE MAMMOGRAM.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD A MAMMOGRAM ON (B)(6) 2012 ON THE LEFT BREAST. STIMULATION WAS NOT TURNED ON DURING THE MAMMOGRAM. THE PATIENT WAS GIVEN THERAPEUTIC ULTRASOUND DURING THE MAMMOGRAM AND SHE FELT HEAT AND A PAIN LIKE AN "ELECTRIC SHOCK" IN HER LEFT ARM AND DOWN HER LEFT LEG. THE NURSE STOPPED THE THERAPY ULTRASOUND WHEN SHE COMPLAINED OF THE PAIN. 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
    95931 PRIMEADVANCED STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37702

    Patients

    Seq Age Sex Outcome Treatment
    1 00081 YR Required Intervention