BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPECIFY

    MDR report key: 5258541 · Received December 1, 2015

    Report

    Report Number
    3007566237-2015-03551
    Event Type
    Injury
    Date Received
    December 1, 2015
    Report Date
    November 6, 2015
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: 37711, SERIAL# (B)(4), IMPLANTED: (B)(6) 2006, PRODUCT TYPE: IMPLANTABLE NEUROSTIMULATOR. PRODUCT ID: 3708340, SERIAL# (B)(4), IMPLANTED: (B)(6) 2006, PRODUCT TYPE: EXTENSION. PRODUCT ID: 3708340, SERIAL# (B)(4), IMPLANTED: (B)(6) 2006, PRODUCT TYPE: EXTENSION. (B)(4).

    Description of Event or Problem · 1

    THE CONSUMER REPORTED THE LEADS WERE LEFT IN. PHYSICIAN LISTINGS WERE PROVIDED TO THE PATIENT REGARDING CURRENT SYMPTOMS WITH THE ABANDONED LEAD. THE PATIENT HAD CHEST PAIN AND UPPER BACK PAIN IN THE MIDDLE OF HER SHOULDERS. IT RADIATES DOWN HER ARMS AND LEGS. IT WAS FROM THE LEADS BEING LEFT IN. THE PATIENT HAD BEEN TO THE PRIMARY CARE PHYSICIAN (PCP) AND THE ER THREE TIMES AND XRAYS SHOW THE LEADS ARE THE CAUSE. THE LEADS ARE FREE FLOATING. THE LEAD ABANDONMENT WAS IN (B)(6) 2015. MEDICAL HISTORY INCLUDES LUMBAR RADICULOPATHY. ADDITIONAL INFORMATION STATED THE PATIENT CALLED BACK TO INQUIRE ABOUT SIGNS/SYMPTOMS OF A LEAD WIRE LEFT IN PLACE AFTER EXPLANT. THE SAME INFORMATION WAS REPEATED. THE PATIENT STATED SHE WAS HAVING SIGNS OF "HEART ATTACK/HIGH BLOOD PRESSURE". PATIENT SERVICES TOLD THE PATIENT THAT SHE NEEDED TO CONSULT WITH A DOCTOR ABOUT THE EXPLANT AND REVIEW THE SYMPTOMS SHE WAS HAVING WITH A DOCTOR TO HAVE THEM DIAGNOSED. ADDITIONAL INFORMATION STATED THE CONSUMER WAS MAKING AN APPOINTMENT WITH A DOCTOR TO ADDRESS THE LEAD IS SUE. SHE STATES SHE WENT TO THE ER THE NIGHT BEFORE; HER BLOOD PRESSURE WAS 203/153 DUE TO HER PAIN LEVEL. THE PATIENT AGREED SHE WOULD CALL AND UPDATE HER SITUATION TO PATIENT SERVICES. IF ADDITIONAL INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    789130 SPECIFY STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC NEUROMODULATION 3998 J0537485V

    Patients

    Seq Age Sex Outcome Treatment
    1 00047 YR Other