BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRIMEADVANCED

    MDR report key: 2852717 · Received November 30, 2012

    Report

    Report Number
    3004209178-2012-10977
    Event Type
    Injury
    Date Received
    November 30, 2012
    Report Date
    November 2, 2012
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID: 39565-65, SERIAL# (B)(4), IMPLANTED: (B)(6) 2012, EXPLANTED: (B)(6) 2012, PRODUCT TYPE: LEAD. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT HAD EXPERIENCED "RIGHT SIDED WEAKNESS." THE PATIENT HAD HAD A CERVICAL LAMINECTOMY ALONG THE CERVICAL IMPLANT OF THE PADDLE LEAD. PATIENT'S DOCTOR SAID HE WAS NOT SURE IF THE PADDLE WAS CAUSING THE PROBLEM OR NOT. THE DOCTOR WANTED TO REMOVE IT JUST IN CASE IT WAS CAUSING THE PROBLEM. HE ALSO REMOVED THE IMPLANTABLE NEUROSTIMULATOR, SINCE THE LEAD HAD BEEN REMOVED AND SINCE THE PATIENT "NO LONGER NEEDED IT." THE PATIENT STATUS WAS REPORTED AS "ALIVE - WITH INJURY." THE EXPLANTED DEVICE WOULD NOT BE RETURNED AS IT WAS DISCARDED. 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
    1 PRIMEADVANCED STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MDT PUERTO RICO OPERATIONS CO 37702

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention