BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPECIFY

    MDR report key: 5252145 · Received November 26, 2015

    Report

    Report Number
    6000153-2015-00323
    Event Type
    Injury
    Date Received
    November 26, 2015
    Report Date
    November 2, 2015
    Manufacturer
    NEURO - VILLALBA
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: 37701, SERIAL# (B)(4), IMPLANTED: (B)(6) 2006, EXPLANTED: (B)(6) 2010, PRODUCT TYPE: IMPLANTABLE NEUROSTIMULATOR. PRODUCT ID: 3708240, SERIAL# (B)(4), IMPLANTED: (B)(6) 2007, PRODUCT TYPE: EXTENSION. PRODUCT ID: 377775, LOT# V021102, IMPLANTED: (B)(6) 2007, PRODUCT TYPE: LEAD. PRODUCT ID: 3708120, SERIAL# (B)(4), IMPLANTED: (B)(6) 2007, PRODUCT TYPE: EXTENSION. (B)(4). THE PATIENT HAS HAD MULTIPLE LEADS THROUGHOUT HIS LIFE IT IS UNCLEAR WHICH HAD THE ISSUE. REFER TO REGULATORY REPORTS 300756623 7-2015-03503, 6000153-2015-00321, 6000153-2015-00322 AND FOR INFORMATION ON THE PATIENT'S OTHER LEADS.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED FROM THE PATIENT REPORTED THAT THE CIRCUMSTANCES THAT LED TO THE LEAD JOSTLING FOR THE 2ND TIME INCLUDED THE FIRST REPOSITIONING WAS NOT GIVING PROPER COVERAGE. STEPS TAKEN TO RESOLVE THE ISSUE INCLUDED THE SAME STEPS TAKEN AFTER THE 1ST TIME, ONLY SLIGHTLY LESS INVASIVE, WHICH INCLUDED REPOSITIONING AND REPLACED THE LEADS AND REMOVAL OF PARTS OF THE VERTEBRAE.

    Description of Event or Problem · 1

    THE PATIENT'S THREE LEADS HAD BEEN JOSTLED ABOUT THREE TIMES. THE LEADS COULD NOT SLIDE IN AS EASILY SO THEY OPENED UP A COUPLE OF VERTEBRAE. THE FIRST ONE MAYBE OCCURRED IN 2006, BUT THE PATIENT DID NOT REMEMBER THE DATES. THE PATIENT'S RELEVANT MEDICAL HISTORY INCLUDED CHRONIC LOW BACK PAIN AND SPINAL PAIN. THE CIRCUMSTANCES THAT LED TO THE LEADS BEING JOSTLED REMAINS UNKNOWN. NO OUTCOME WAS REPORTED REGARDING THIS EVENT. FOLLOW-UP IS BEING CONDUCTED TO OBTAIN THIS INFORMATION. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW-UP REPORT WILL BE SENT. PLEASE SEE MANUFACTURER REPORT #6000153-2015-00322 FOR INFORMATION ON THE PATIENT'S OTHER LEAD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    782561 SPECIFY STIMULATOR, SPINAL-CORD, IMPLANTED (PAIN RELIEF) LGW NEURO - VILLALBA 3998 V029383

    Patients

    Seq Age Sex Outcome Treatment
    1 00051 YR Required Intervention