BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PISCES-QUAD

    MDR report key: 5256279 · Received November 30, 2015

    Report

    Report Number
    6000153-2015-00335
    Event Type
    Injury
    Date Received
    November 30, 2015
    Date of Event
    February 6, 2015
    Report Date
    November 5, 2015
    Manufacturer
    NEURO - VILLALBA
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: 37714, SERIAL# (B)(4), IMPLANTED: (B)(6) 2012, PRODUCT TYPE: IMPLANTABLE NEUROSTIMULATOR. PRODUCT ID: 37744, SERIAL# (B)(4), PRODUCT TYPE: PROGRAMMER, PATIENT. PRODUCT ID: 3888-45, LOT# VA049HT, IMPLANTED: (B)(6) 2015, PRODUCT TYPE: LEAD. PRODUCT ID: 3888-33, LOT# V882270, IMPLANTED: (B)(6) 2015, PRODUCT TYPE: LEAD. PRODUCT ID: 3487A-33, LOT# V208707, IMPLANTED: (B)(6) 2012, PRODUCT TYPE: LEAD. PRODUCT ID: 3708220, SERIAL# (B)(4), IMPLANTED: (B)(6) 2012, PRODUCT TYPE: EXTENSION. PRODUCT ID: 3708240, SERIAL# (B)(4), IMPLANTED: (B)(6) 2012,SERIAL# (B)(4), IMPLANTED: (B)(6) 2015, PRODUCT TYPE: EXTENSION. (B)(4).

    Description of Event or Problem · 1

    THE PATIENT REPORTED BEING IN A CAR ACCIDENT, WHICH MIGHT HAVE CAUSED THEM TO BECOME DISLODGED. THE LEAD REVISION OCCURRED ON (B)(6) 2015. THE PATIENT'S RELEVANT MEDICAL HISTORY INCLUDES NON-MALIGNANT PAIN

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    784634 PISCES-QUAD STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW NEURO - VILLALBA 3487A-33 V825340

    Patients

    Seq Age Sex Outcome Treatment
    1 00056 YR Required Intervention