BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRIMEADVANCED

    MDR report key: 6578652 · Received May 19, 2017

    Report

    Report Number
    3004209178-2017-10691
    Event Type
    Injury
    Date Received
    May 19, 2017
    Report Date
    June 2, 2017
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    LGW
    UDI-DI
    00613994842312
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    SECTION D INFORMATION REFERENCES THE MAIN COMPONENT OF THE SYSTEM AND OTHER APPLICABLE COMPONENTS ARE: PRODUCT ID: 3998, LOT# V113343, IMPLANTED: (B)(6) 2008, EXPLANTED: (B)(6) 2017, PRODUCT TYPE: LEAD. PRODUCT ID: 3708240, SERIAL# (B)(4), IMPLANTED: (B)(6) 2008, EXPLANTED: (B)(6) 2017, PRODUCT TYPE: EXTENSION. PRODUCT ID: 3550-29, SERIAL# UNKNOWN, PRODUCT TYPE: ACCESSORY. PRODUCT ID: 3550-39, SERIAL# UNKNOWN, PRODUCT TYPE: ACCESSORY. PRODUCT ID: NEU_SILICONEANCHOR, SERIAL# UNKNOWN, 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.

    Additional Manufacturer Narrative · 1

    ANALYSIS OF THE (INS) (LOT# OR SERIAL#, IF APPROPRIATE) FOUND ((B)(4)). THE RETURNED {DEVICE} PASSED ALL {FUNCTIONAL} TESTING IN THE LABORATORY. NO ANOMALIES WERE IDENTIFIED. THE INS PASSED THE FINAL FUNCTIONAL TEST ON THE AUTOMATED TEST CONSOLE. A LAB FUNCTIONAL TEST DETERMINED THERE WAS GOOD STABLE OUTPUT ON THE ELECTRODE PAIRS THE INS HAD WHEN IT WAS RECEIVED. A LAB FUNCTIONAL TEST DETERMINED THERE WAS GOOD STABLE OUTPUT ON ALL ELECTRODE PAIRS. ANALYSIS DETERMINED THERE WERE NO ISSUES WHEN PRESSING ON THE INS CAN. ANALYSIS DETERMINED THE TELEMETRY WAS ACCEPTABLE. A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER (HCP) REGARDING A PATIENT. IT WAS REPORTED THAT THE PATIENT WAS INVOLVED IN A MOTOR VEHICLE ACCIDENT. THE HCP REPORTED THAT THE PATIENT¿S DEVICE WAS DAMAGED. IT WAS NOTED THAT THE ACCIDENT OCCURRED ON (B)(6) 2017. THE PATIENT¿S SYSTEM WAS EXPLANTED ON THAT DAY. NO PATIENT SYMPTOMS WERE REPORTED AND THERE WERE NO FURTHER COMPLICATIONS. INDICATIONS FOR USE WERE SPINAL PAIN AND COMPLEX REGIONAL PAIN SYNDROME TYPE I.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    359011 PRIMEADVANCED STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37702 00613994842312

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention