BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PISCES-QUAD

    MDR report key: 5330622 · Received December 28, 2015

    Report

    Report Number
    6000153-2015-00662
    Event Type
    Injury
    Date Received
    December 28, 2015
    Report Date
    November 30, 2015
    Manufacturer
    NEURO - VILLALBA
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: 3888-56, LOT# VA0ANTH, IMPLANTED: (B)(6) 2014, PRODUCT TYPE: LEAD. PRODUCT ID: 3888-56, LOT# VA09UN2, IMPLANTED: (B)(6) 2014, PRODUCT TYPE: LEAD. PRODUCT ID: 3708260, SERIAL# (B)(4), IMPLANTED: (B)(6) 2013, PRODUCT TYPE: EXTENSION. PRODUCT ID: 3708260, SERIAL# (B)(4), IMPLANTED: (B)(6) 2013, PRODUCT TYPE: EXTENSION. PRODUCT ID: 3987A, LOT# N270796, IMPLANTED: (B)(6) 2013, PRODUCT TYPE: LEAD. PRODUCT ID: 3708340, SERIAL# (B)(4), IMPLANTED: (B)(6) 2013, PRODUCT TYPE: EXTENSION. PRODUCT ID: 39565-65, SERIAL# (B)(4), IMPLANTED: (B)(6) 2013, PRODUCT TYPE: LEAD. PRODUCT ID: 3888-56, LOT# VA08QWY, IMPLANTED: (B)(6) 2013, PRODUCT TYPE: LEAD. PRODUCT ID: 3888-56, LOT# VA07FKN, IMPLANTED: (B)(6) 2013, PRODUCT TYPE: LEAD. PRODUCT ID: 3987A, LOT# N370329, IMPLANTED: (B)(6) 2013, PRODUCT TYPE: LEAD. (B)(4). INFORMATION INDICATES THAT ¿MANY OF THE CABLES AND WIRES WERE REMOVED.¿ IT IS UNKNOWN WHICH OF THE IMPLANTED LEADS AND EXTENSIONS WERE REMOVED. SEE MFR REPORTS #6000153-2015-00651/6000153-2015-00652/6000153- 2015-00653/6000153-2015-00656/6000153-2015-00657/600 0153-2015-00658/3007566237-2015-04083/6000153-2015-00659/6000153-2015-00660/6000153-2015-00661 FOR THE REPORT ON THE OTHER POTENTIAL LEADS AND EXTENSIONS.

    Description of Event or Problem · 1

    INFORMATION WAS RECEIVED FROM A CONSUMER REGARDING A PATIENT WHO WAS IMPLANTED WITH A NEUROSTIMULATOR FOR SPINAL PAIN, BILATERAL TRIGEMINAL NEURALGIA AND COMPLEX REGIONAL PAIN SYNDROME (CRPS). IT WAS NOTED THAT THE PATIENT CURRENTLY HAD 4 IMPLANTABLE NEUROSTIMULATORS (INS). IT WAS REPORTED THAT ON (B)(6) 2015 THE PATIENT HAD MANY OF THE CABLES AND WIRES REMOVED BECAUSE AN INFECTION HAD GOTTEN INTO THE MAIN INCISION ON THE TOP LEFT SHOULDER. THE LEADS THAT WERE REMOVED WERE THE ONES THAT WERE PERTINENT TO THE INFECTION. THE HEALTHCARE PROVIDER (HCP) LEFT THE INSS AND SOME LEADS AND ONE OF THE INS WAS STILL ACTIVE. FURTHER FOLLOW-UP IS BEING CONDUCTED TO DETERMINE WHICH DEVICES WERE REMOVED. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW-UP REPORT WILL BE SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    854433 PISCES-QUAD STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW NEURO - VILLALBA 3888-56 VA07FKN

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention