BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRIMEADVANCED

    MDR report key: 2984399 · Received February 28, 2013

    Report

    Report Number
    3004209178-2013-03192
    Event Type
    Injury
    Date Received
    February 28, 2013
    Report Date
    February 14, 2013
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NV, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 39565-65, SERIAL# (B)(4), IMPLANTED: (B)(6) 2011, EXPLANTED: (B)(6) 2011. PRODUCT TYPE: LEAD: PRODUCT ID 39565-65, SERIAL# (B)(4), IMPLANTED: (B)(6) 2011. PRODUCT TYPE: LEAD: PRODUCT ID 37743, SERIAL# (B)(4). PRODUCT TYPE: PROGRAMMER, PATIENT: PRODUCT ID 37092, LOT# 271470001, IMPLANTED: (B)(6) 2011. PRODUCT TYPE: ACCESSORY. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT'S PHYSICIAN THAT WAS TO INSTALL THE IMPLANTABLE NEUROSTIMULATOR "SCREWED IT UP 3 TIMES." DUE TO THE ATTEMPTED PLACEMENTS, THE PATIENT HAD TOO MUCH SCAR TISSUE TO ATTEMPT AGAIN. IT WAS REPORTED AS "TOO RISKY OF PROCEDURE TO TRY TO DO IT AGAIN." THE PATIENT HAD ALL COMPONENTS OF THE SPINAL CORD STIMULATION SYSTEM REMOVED. 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
    89065 PRIMEADVANCED STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37702

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention