BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN IMPLANTABLE NEUROSTIMULATOR

    MDR report key: 3252935 · Received July 29, 2013

    Report

    Report Number
    3004209178-2013-12444
    Event Type
    Injury
    Date Received
    July 29, 2013
    Report Date
    July 4, 2013
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LNQ
    PMA / PMN Number
    H990014
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID 435135, SERIAL# (B)(4), IMPLANTED: (B)(6) 2012, PRODUCT TYPE LEAD; PRODUCT ID 435135, SERIAL# (B)(4), IMPLANTED: (B)(6) 2012, PRODUCT TYPE LEAD. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    ADDITIONAL REVIEW INDICATES THAT THE MODEL #, CATALOG #, EXPIRATION DATE, AND SERIAL # ARE UNKNOWN. ADDITIONAL REVIEW INDICATES THAT THE IMPLANTED DATE IS UNKNOWN. (B)(4). ADDITIONAL REVIEW INDICATES THAT THE DEVICE MFG DATE IS UNKNOWN.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WAS IN A HOSPITAL AND FELT LIKE HER "STOMACH WAS BEING RIPPED IN TWO". THE PATIENT HAD BEEN HAVING ISSUES SINCE A CAR ACCIDENT TWO MONTHS AGO AND IT WAS NOTED THAT SHE HAD SEEN HER HCP THE PREVIOUS WEEK. ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE LEAD ¿MALPOSITIONED¿, DISLODGED OR MIGRATED, AND THE BATTERY PART WAS ATTRIBUTED TO THE EVENT. IT WAS REPORTED A SURGICAL REVISION OCCURRED AND THE PATIENT WAS HOSPITALIZED. IT WAS REPORTED THAT THE NEUROSTIMULATOR WAS REPOSITIONED WITH REPROGRAMMING. A CT SCAN AND REPROGRAMMING WERE PERFORMED ON (B)(6) 2012. IT WAS REPORTED THAT RESULTS SHOWED THE PACER LEADS APPEARED ¿GROSSLY INTACT THROUGHOUT ENTIRE COURSE.¿ IMPEDANCES WERE REPORTED AS 523, CURRENT AT 5, VOLTAGE AT 2.6 / 2 / 6, PULSE WIDTH AT 330, AND THE RATE AT 2.8 ¿ ¿ON 2.0 OFF 3.0¿. IT WAS REPORTED THAT THE PATIENT HAD ¿SEVERE ABDOM[INAL] PAIN¿ AND NAUSEA. THE PATIENT¿S OUTCOME WAS REPORTED AS A NON-SERIOUS INJURY/ILLNESS.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE DEVICE WAS REPLACED BECAUSE THE PATIENT GOT IN A CAR ACCIDENT AND HER SEAT BELT WAS WHERE THE IMPLANTABLE NEUROSTIMULATOR (INS) WAS. THE PATIENT WAS GETTING SHOCKED IN RANDOM PLACES IN (B)(6) 2013. IT WAS UNCLEAR IF THE DEVICE WAS REPLACED OR REVISED, AS IT WAS PREVIOUSLY REPORTED THAT THE DEVICE WAS REVISED. PLEASE SEE MFR. REPORTS #3007566237-2014-02345 AND #3007566237-2014-02347 FOR INFORMATION ABOUT THE PATIENT'S PREVIOUS DEVICE REPLACEMENTS. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT. A FOLLOW-UP REPORT WILL BE MADE IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    352144 UNKNOWN IMPLANTABLE NEUROSTIMULATOR INTESTINAL STIMULATOR LNQ MEDTRONIC NEUROMODULATION 3116

    Patients

    Seq Age Sex Outcome Treatment
    1 00024 YR Hospitalization| R