BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN IMPLANTABLE NEUROSTIMULATOR

    MDR report key: 5482196 · Received March 5, 2016

    Report

    Report Number
    3007566237-2016-01259
    Event Type
    Injury
    Date Received
    March 5, 2016
    Date of Event
    January 1, 2001
    Report Date
    February 5, 2016
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS NOT POSSIBLE TO ASCERTAIN SPECIFIC DEVICE INFORMATION FROM THE ARTICLE OR TO MATCH THE EVENTS REPORTED WITH PREVIOUSLY REPORTED EVENTS. CORRESPONDENCE HAS BEEN SENT TO THE AUTHOR OF THE ARTICLE INQUIRING ABOUT INDIVIDUAL PATIENT INFORMATION AND ADDITIONAL INFORMATION REGARDING THE REPORTED EVENTS. SECTION D INFORMATION REFERENCES THE MAIN COMPONENT OF THE SYSTEM AND OTHER APPLICABLE COMPONENTS ARE: PRODUCT ID NEU_UNKNOWN_LEAD, LOT # UNKNOWN, PRODUCT TYPE LEAD. (B)(4).

    Description of Event or Problem · 1

    BERIC, A., KELLY, P.J., REZAI, A., STERIO, D., MOGILNER, A., ZONENSHAYN, M., KOPELL, B. COMPLICATIONS OF DEEP BRAIN STIMULATION SURGERY. STEREOTACTIC AND FUNCTIONAL NEUROSURGERY. 2001; 77(1-4): 73-78. SUMMARY: ALTHOUGH TECHNOLOGICAL ADVANCES HAVE REDUCED DEVICE-RELATED COMPLICATIONS, DEEP BRAIN STIMULATION (DBS)SURGERY STILL CARRIES A SIGNIFICANT RISK OF TRANSIENT AND PERMANENT COMPLICATIONS. WE REPORT OUR EXPERIENCE IN 86 PATIENTS AND 149 DBS IMPLANTS. PATIENTS WITH PARKINSON'S DISEASE, ESSENTIAL TREMOR AND DYSTONIA WERE TREATED. REPORTED EVENTS: [MALE-PD] 1 PATIENT UNDERWENT DEEP BRAIN STIMULATION (DBS) PLACEMENT FOR PARKINSON'S DISEASE AND EXPERIENCED PERIOPERATIVE INTRACRANIAL HEMORRHAGE. THE PATIENT HAD A GENERALIZED SEIZURE DURING THE RECORDING PORTION OF THE SURGERY. AN IMMEDIATE POSTOPERATIVE CT SCAN WAS UNREMARKABLE. HE DEVELOPED A DENSE HEMIPARESIS ON THE SECOND POSTOPERATIVE DAY. CT SCANNING THEN REVEALED A 3X4 CM FRONTAL HEMATOMA. THE HEMATOMA WAS EVACUATED. HIS HEMIPARESIS IMPROVED IN THE FOLLOWING WEEKS AND AT 6 WEEKS HIS STRENGTH HAD RETURNED TO NORMAL. TWENTY-FOUR MONTHS AFTER THE SURGERY, IN WHICH NO DBS SYSTEM WAS PLACED, THIS PATIENT CONTINUED TO EXHIBIT CLINICAL IMPROVEMENT OF PD SYMPTOMS WHEN COMPARED TO HIS PREOPERATIVE CONDITION. HOWEVER, IN THE YEAR PRIOR TO PUBLICATION OF THIS ARTICLE, HE HAD 4 EPISODES OF CONFUSION, POSSIBLY SEIZURES, AND WAS ON ANTICONVULSANT MEDICATION. THE ¿PRESUMED PARTIAL COMPLEX SEIZURES¿ WERE NOTED TO BE PERMANENT SEQUELAE. THE SOURCE LITERATURE DID NOT INCLUDE ANY SPECIFIC DEVICE INFORMATION. FURTHER INFORMATION HAS BEEN REQUESTED; A SUPPLEMENTAL REPORT WILL BE SUBMITTED IF ADDITIONAL INFORMATION IS RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    138656 UNKNOWN IMPLANTABLE NEUROSTIMULATOR STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC NEUROMODULATION NEU_INS_STIMULATOR UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Other| R