BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PISCES-QUAD

    MDR report key: 3002028 · Received March 13, 2013

    Report

    Report Number
    3007566237-2013-00763
    Event Type
    Malfunction
    Date Received
    March 13, 2013
    Report Date
    February 22, 2013
    Manufacturer
    NEURO - VILLALBA
    Product Code
    GZB
    PMA / PMN Number
    P840001
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 3888-56, LOT# VA05LB7, IMPLANTED: (B)(6) 2013. PRODUCT TYPE: LEAD: PRODUCT ID 3708220, SERIAL# (B)(4), IMPLANTED: (B)(6) 2013. PRODUCT TYPE: EXTENSION: PRODUCT ID 3708240, SERIAL# (B)(4), IMPLANTED: (B)(6) 2013. PRODUCT TYPE: EXTENSION: PRODUCT ID 3888-56, LOT# V866966, IMPLANTED: (B)(6) 2013. PRODUCT TYPE: LEAD: PRODUCT ID 3888-56, LOT# V849273, IMPLANTED: (B)(6) 2013. PRODUCT TYPE: LEAD: PRODUCT ID 37754, SERIAL# (B)(4). PRODUCT TYPE: RECHARGER: PRODUCT ID 37714, SERIAL# (B)(4), IMPLANTED: (B)(6) 2013. PRODUCT TYPE: IMPLANTABLE NEUROSTIMULATOR: PRODUCT ID 37746, SERIAL# (B)(4). PRODUCT TYPE: PROGRAMMER, PATIENT. THE INITIAL MDR WAS FILED AS MFR REPORT # 3007566237-2013-00763. ADDITIONAL REVIEW INDICATED THE CORRECT MANUFACTURING SITE WAS SITE # (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT IMPEDANCE MEASUREMENTS WERE FINE, THE LEAD WAS IMPLANTED, AND STIMULATION WAS GOOD.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING THE PROCESS OF IMPLANTING A LEAD BLOOD WAS NOTICED INSIDE THE LEAD TOWARD THE MIDDLE, BETWEEN BOTH SETS OF ELECTRODES. IT WAS NOTED THAT THE STYLET HADN'T BEEN REMOVED FROM THE LEAD. THE HCP WAS ABLE TO "WASH OR PLACE THE LEAD IN A BATH AND SAW THE BLOOD LIGHTEN IN COLOR". 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
    104628 PISCES-QUAD STIMULATOR, SPINAL-CORD, IMPLANTED (PAIN RELIEF) GZB NEURO - VILLALBA 3888-56 VA0588P

    Patients

    Seq Age Sex Outcome Treatment
    1