BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRIMEADVANCED

    MDR report key: 4848883 · Received June 16, 2015

    Report

    Report Number
    3004209178-2015-11716
    Event Type
    Injury
    Date Received
    June 16, 2015
    Report Date
    May 28, 2015
    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
    WI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE PATIENT WAS SCHEDULED FOR A FULL SYSTEM EXPLANT; EVERYTHING WAS EXPLANTED, EXCEPT FOR ONE OF THE BOOTS FROM THE BIFURCATED EXTENSIONS. CONCOMITANT PRODUCTS: PRODUCT ID 3708220, SERIAL # (B)(4), IMPLANTED: (B)(6) 2009, PRODUCT TYPE EXTENSION; PRODUCT ID 37712, SERIAL # (B)(4), IMPLANTED: (B)(6) 2011, PRODUCT TYPE IMPLANTABLE NEUROSTIMULATOR; PRODUCT ID 3888-45, LOT # V836593, IMPLANTED: (B)(6) 2012, EXPLANTED: (B)(6) 2015, PRODUCT TYPE LEAD; PRODUCT ID 3888-56, LOT # V661669, IMPLANTED: (B)(6) 2012, PRODUCT TYPE LEAD; PRODUCT ID 3888-56, LOT # V661669, IMPLANTED: (B)(6) 2012, PRODUCT TYPE LEAD; PRODUCT ID 37082-40, SERIAL # (B)(4), IMPLANTED: (B)(6) 2012, EXPLANTED: (B)(6) 2015, PRODUCT TYPE EXTENSION; PRODUCT ID 3708240, SERIAL # (B)(4), IMPLANTED: (B)(6) 2012, EXPLANTED: (B)(6) 2015, PRODUCT TYPE EXTENSION; PRODUCT ID 3888-45, LOT # V836593, IMPLANTED: (B)(6) 2012, EXPLANTED: (B)(6) 2015, PRODUCT TYPE LEAD; PRODUCT ID 37744, SERIAL # (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT; PRODUCT ID 3888-45, LOT # V193017, IMPLANTED: (B)(6) 2009, PRODUCT TYPE LEAD; PRODUCT ID 3888-45, LOT # V193017, IMPLANTED: (B)(6) 2009, PRODUCT TYPE LEAD; PRODUCT ID 3778-60, SERIAL # (B)(4), IMPLANTED: (B)(6) 2009, EXPLANTED: (B)(6) 2015, PRODUCT TYPE LEAD; PRODUCT ID 37743, SERIAL # (B)(4), IMPLANTED: (B)(6) 2009, PRODUCT TYPE PROGRAMMER, PATIENT. (B)(4).

    Additional Manufacturer Narrative · 1

    ANALYSIS OF THE INS (S/N (B)(4)), FOUND NO SIGNIFICANT ANOMALIES. THE BATTERY WAS AT NORMAL END OF LIFE, AND TELEMETRY AND OUTPUT WERE OKAY. ANALYSIS OF THE EXTENSIONS (S/N (B)(4)), FOUND NO ANOMALIES.

    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.

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT¿S IMPLANTABLE PULSE GENERATOR (IPG) HAD REACHED THE NORMAL ELECTIVE REPLACEMENT INDICATOR (ERI). INSTEAD OF HAVING A REPLACEMENT, THE PATIENT DECIDED TO HAVE THE DEVICE EXPLANT BECAUSE SHE FELT IT WAS NOT HELPING. SYSTEM EXPLANT WAS PLANNED FOR (B)(6) 2015. DIAGNOSTIC TESTING OR TROUBLESHOOTING WAS NOT PERFORMED OR REQUIRED, AND THE PATIENT¿S STATUS WAS ALIVE WITH NO INJURY AT THE INITIAL TIME OF REPORT. ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE PATIENT HAD A FULL EXPLANT OF THE LEADS, EXTENSION, AND IMPLANTABLE PULSE GENERATOR (IPG). EVERYTHING WAS EXPLANTED, EXCEPT ONE OF THE BOOTS FROM THE BIFURCATED EXTENSIONS IN THE SUBCUTANEOUS TISSUE NEAR THE POCKET. THE PATIENT WAS INFORMED OF THIS, AND IT WAS NOTED THAT SHE WAS OKAY WITH IT. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW UP REPORT WILL BE SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    389914 PRIMEADVANCED STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37702

    Patients

    Seq Age Sex Outcome Treatment
    1 Other