BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN IMPLANTABLE NEUROSTIMULATOR

    MDR report key: 5482297 · Received March 5, 2016

    Report

    Report Number
    3007566237-2016-01287
    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

    DATE OF EVENT: PLEASE NOTE THAT THIS DATE IS BASED OFF OF THE YEAR OF PUBLICATION OF THE ARTICLE AS THE EVENT DATES WERE NOT PROVIDED IN THE PUBLISHED LITERATURE. 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. CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID NEU_UNKNOWN_LEAD, PRODUCT TYPE: LEAD. PRODUCT ID NEU_UNKNOWN_EXT, PRODUCT TYPE: EXTENSION. PRODUCT ID NEU_UNKNOWN_EXT, PRODUCT TYPE: EXTENSION. PRODUCT ID NEU_UNKNOWN_EXT, PRODUCT TYPE: EXTENSION. PRODUCT ID NEU_INS_STIMULATOR, PRODUCT TYPE: IMPLANTABLE NEUROSTIMULATOR. PRODUCT ID NEU_INS_STIMULATOR, PRODUCT TYPE: IMPLANTABLE NEUROSTIMULATOR. PRODUCT ID NEU _INS_STIMULATOR, PRODUCT TYPE: IMPLANTABLE NEUROSTIMULATOR. PRODUCT ID NEU_INS_STIMULATOR, PRODUCT TYPE: IMPLANTABLE NEUROSTIMULATOR. PRODUCT ID NEU_INS_STIMULATOR, PRODUCT TYPE: IMPLANTABLE NEUROSTIMULATOR. PRODUCT ID NEU_INS_STIMULATOR, PRODUCT TYPE: IMPLANTABLE NEUROSTIMULATOR. PRODUCT ID NEU_INS_STIMULATOR., PRODUCT TYPE: IMPLANTABLE NEUROSTIMULATOR. PRODUCT ID NEU_INS_STIMULATOR, PRODUCT TYPE IMPLANTABLE NEUROSTIMULATOR. PRODUCT ID NEU_INS_STIMULATOR, PRODUCT TYPE: IMPLANTABLE NE UROSTIMULATOR. PRODUCT ID NEU_INS_STIMULATOR, PRODUCT TYPE: IMPLANTABLE NEUROSTIMULATOR. PRODUCT ID NEU_INS_STIMULATOR, PRODUCT TYPE: IMPLANTABLE NEUROSTIMULATOR. PRODUCT ID NEU_I NS_STIMULATOR, PRODUCT TYPE: IMPLANTABLE NEUROSTIMULATOR. (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. DOI: 10.1159/000064600. SUMMARY: ALTHOUGH TECHNOLOGICAL ADVANCES HAVE REDUCED DEVICE-RELATED COMPLICATIONS, 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 WITHOUT PATIENT IDENTIFIERS: 2 PATIENTS UNDERWENT DBS IMPLANT AND EXPERIENCED A SINGLE GENERALIZED SEIZURE INTRAOPERATIVELY. SURGERY WAS ABORTED IN BOTH CASES. THEY WERE PLACED ON ANTICONVULSANTS AND AN UNEVENTFUL DBS IMPLANTATION WAS CARRIED OUT SIX WEEKS LATER. THERE WAS NO PERSISTENT SEQUELA NOTED; 3 PATIENTS WITH DBS EXPERIENCED DBS ELECTRODE FAILURE (SUBTHALAMIC NUCLEUS [STN] ELECTRODES IN 2 PATIENTS AND THALAMIC DBS IN 1 PATIENT). THESE PATIENTS REQUIRED BRAIN SURGERY FOR REPLACEMENT. THERE WAS NO PERSISTENT SEQUELA NOTED; 2 PATIENTS WITH DBS EXPERIENCED EXTENSION WIRE MALFUNCTION AND REQUIRED REPLACEMENT UNDER GENERAL ANESTHESIA. THERE WAS NO PERSISTENT SEQUELA NOTED; 1 PATIENT WITH DBS EXPERIENCED EXTENSION WIRE MALFUNCTION. THERE WAS NO PERSISTENT SEQUELA NOTED; 1 PATIENT WITH DBS EXPERIENCED EXTENSION WIRE FAILURE AND REQUIRED RE-EXPLORATION OF THESUBCLAVICULAR INCISION TO RECTIFY AN INCOMPLETE CONNECTION TO THE PULSE GENERATOR. THERE WAS NO PERSISTENT SEQUELA NOTED; 1 PATIENT WITH DBS EXPERIENCED PULSE GENERATOR MALFUNCTION. THE PULSE GENERATOR ALTERNATED INTERMITTENTLY AND SPONTANEOUSLY BETWEEN THE ON AND OFF STATES. THE MALFUNCTION WAS NOTED TO BE ¿UNEXPLAINED¿ AND REQUIRED REPLACEMENT. THERE WAS NO PERSISTENT SEQUELA NOTED; 1 PATIENT WITH DBS EXPERIENCED PERSISTENT PAIN OVER THE IMPLANTED PULSE GENERATOR SITE. THIS RESOLVED FOLLOWING SURGICAL REPOSITIONING. THERE WAS NO PERSISTENT SEQUELA NOTED; 1 PATIENT UNDERWENT DBS IMPLANT AND EXPERIENCED POSTOPERATIVE PERIPHERAL NERVE INJURY. THE PATIENT AWOKE WITH AN IPSILATERAL SHOULDER DROP FOLLOWING UNILATERAL THALAMIC DBS SURGERY. THIS WAS DUE TO AN ACCESSORY NERVE PARALYSIS WHICH HAD NOT RESOLVED DURING THE TWO YEARS FOLLOWING SURGERY. THIS WAS NOTED TO BE PERMANENT SEQUELAE OF AXILLARY NERVE PALSY; 1 PATIENT WITH DBS EXPERIENCED POSTOPERATIVE PERIPHERAL NERVE INJURY. THE PATIENT DEVELOPED SEVERE ONE-SIDED SHOULDER PAIN AND ABDUCTION WEAKNESS AFTER BILATERAL SUBTHALAMIC NUCLEUS (STN) DBS SURGERY. A PARTIAL SUPRASCAPULAR NERVE DYSFUNCTION WAS IDENTIFIED BUT COMPLETELY RESOLVED FOLLOWING A FEW WEEKS OF CONSERVATIVE TREATMENT. THERE WAS NO PERSISTENT SEQUELA NOTED. 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
    138661 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