BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN EXTERNAL STIMULATOR

    MDR report key: 2941925 · Received February 4, 2013

    Report

    Report Number
    3007566237-2013-00359
    Event Type
    Injury
    Date Received
    February 4, 2013
    Report Date
    January 10, 2013
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    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: 37702, SERIAL# (B)(4), IMPLANTED: (B)(6) 2011, PRODUCT TYPE: IMPLANTABLE NEUROSTIMULATOR. (B)(4).

    Description of Event or Problem · 1

    AFTER ADDITIONAL REVIEW THE FOLLOWING INFORMATION THAT WAS REPORTED DOES NOT PERTAIN TO THIS DEVICE SYSTEM: IT WAS REPORTED THE PATIENT NEVER HAD THERAPEUTIC EFFECT FOR THEIR LOW BACK AND THAT STIMULATION WAS IN THEIR LEGS ONLY. IT WAS NOTED THERE HAD NOT BEEN ANY IMAGING DONE TO CHECK LEAD PLACEMENT. IT WAS ALSO NOTED THE PATIENT WAS PREPARING TO HAVE SURGERY ON THEIR LOW BACK BECAUSE THEY HAD ANOTHER DISC 'BLOWN OUT.'

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT NEVER HAD THERAPEUTIC EFFECT FOR THEIR LOW BACK AND THAT STIMULATION WAS IN THEIR LEGS ONLY. IT WAS NOTED THE PATIENT WAS IN THE HOSPITAL FOR "EIGHT DAYS" FOR THEIR TRIAL. IT WAS NOTED AT SOME POINT DURING THE TRIAL THE PATIENT'S COLON WAS "PARTIALLY PARALYZED." IT WAS NOTED THAT EVEN DURING THE TRIAL THE PATIENT DID NOT GET RELIEF FROM THEIR LOW BACK PAIN AND ONLY HAD STIMULATION IN THEIR LEGS. AT THE END OF THE EIGHT DAYS IT WAS NOTED THE PATIENT WENT FORWARD WITH THE IMPLANT. THE REPORTER NOTED THAT PATIENT WENT FORWARD WITH THE IMPLANT BECAUSE "IT WAS RECOMMENDED BY THE HEALTH CARE PROVIDER." IT WAS NOTED THERE HAD NOT BEEN ANY IMAGING DONE TO CHECK LEAD PLACEMENT. IT WAS ALSO NOTED THE PATIENT WAS PREPARING TO HAVE SURGERY ON THEIR LOW BACK BECAUSE THEY HAD ANOTHER DISC "BLOWN OUT." ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT; A FOLLOW-UP REPORT WILL BE SENT IF INFORMATION BECOMES AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    46310 UNKNOWN EXTERNAL STIMULATOR STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC NEUROMODULATION NEU_ENS_STIMULATOR

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization