BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN IMPLANTABLE NEUROSTIMULATOR

    MDR report key: 3910457 · Received July 2, 2014

    Report

    Report Number
    3007566237-2014-01856
    Event Type
    Injury
    Date Received
    July 2, 2014
    Date of Event
    June 12, 2014
    Report Date
    June 13, 2014
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CEREBRAL HEMORRHAGE. CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 3389-28, SERIAL# (B)(4), IMPLANTED: (B)(6) 2014, EXPLANTED: (B)(6) 2014, PRODUCT TYPE: LEAD; PRODUCT ID 3708660, SERIAL# (B)(4), IMPLANTED: (B)(6) 2014, EXPLANTED: (B)(6) 2014, PRODUCT TYPE: EXTENSION. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT ¿SUFFERED A CEREBRAL HEMORRHAGE¿ WHILE UNDERGOING THE USE OF A NAVIGATION SYSTEM DURING DEEP BRAIN STIMULATION (DBS) SURGERY. ADDITIONAL INFORMATION REPORTED THE PATIENT WAS IMPLANTED WITH A DBS ELECTRODE IN THEIR LEFT SUB-THALAMIC NUCLEUS (STN) TWO DAYS PRIOR TO REPORT. IT WAS STATED THAT CT IMAGES WERE TAKEN AFTER THE FRAME WAS INSTALLED FOR THE PROCEDURE. IT WAS FURTHER STATED THAT AFTER A LEAD WAS INSERTED FOR MONITORING THAT THE DBS LEAD WAS PLACED. IT WAS REPORTED THAT NO HEMORRHAGE WAS OBSERVED AT THAT TIME. AROUND DAWN OF THE DAY AFTER IMPLANT IT WAS FOUND THAT ¿SOMETHING WAS WRONG WITH THE PATIENT,¿ SO THE PATIENT¿S PHYSICIAN WAS CALLED IN TO SEE THE PATIENT AND AT THAT TIME THE PHYSICIAN HAD CONFIRMED ¿THE PATIENT HAD INTRACEREBRAL HEMORRHAGE AFTER THE SURGERY.¿ IT WAS STATED THAT ¿A SURGERY WAS PERFORMED TO ELIMINATE HEMATOMA.¿ ON THE DAY OF REPORT IT WAS STATED THAT ¿A SURGERY FOR INTERNAL AND EXTERNAL DECOMPRESSION WAS PERFORMED¿ AND THAT THE PATIENT¿S ENTIRE DBS SYSTEM WAS REMOVED AT THAT TIME. IT WAS REPORTED ¿THE HEMORRHAGE SITE WAS NEAR THE BRAIN SURFACE, NEXT TO THE TRACT (PUNCTURE) SITE, AND IT SEEMED THERE WAS A CONSIDERABLY GREAT AMOUNT OF BLEEDING.¿ IT WAS NOTED BY A PHYSICIAN WHO HAD ATTENDED THE IMPLANT PROCEDURE THAT ¿THE HEMORRHAGE SITE WAS CLOSE TO THE TRACT, HOWEVER, THE BLEEDING SITE DID NOT CONTACT THE TRACT.¿ IT WAS STATED THAT ¿THIS MEANT THE HEMORRHAGE HAD NOT RESULTED FROM A BLOOD VESSEL BEING CAUGHT BY A PORTION OF THE DEVICE DURING THE SURGERY.¿ IT WAS REPORTED THAT ¿WHEN THE CRANIUM WAS OPENED, A LARGE VEIN WAS VISIBLE AND A MINOR HEMORRHAGE FROM THE VESSEL WAS OBSERVED, WHICH WAS CONTROLLED BY A CAUTERY DURING THE SURGERY.¿ IT WAS FURTHER REPORTED THAT ¿IT SEEMED THIS WAS A VENOUS INFARCTION WHICH SEEMED [TO BE] CAUSING THE EVENT LATER.¿ IT WAS STATED THE PATIENT¿S BLEEDING HAD OCCURRED WITHIN 24 HOURS AFTER THEIR IMPLANT PROCEDURE. IT WAS REPORTED ¿THE PHYSICIAN MENTIONED THAT THE EVENT WAS CAUSED BY PATIENT-DERIVED OTHER FACTORS, RATHER THAN A DEFECT OF THE PRODUCT.¿ IT WAS FURTHER REPORTED THERE WERE ¿PATIENT-DERIVED¿ FACTORS THAT INCLUDED ¿BRAIN FRAGILITY¿ THAT ¿MIGHT HAVE BEEN THE CAUSE OF THE EVENT.¿ IT WAS NOTED THAT ¿THE PATIENT SUFFERED FROM APHASIA, PALSY, AND DYSPHAGIA WHICH REQUIRED A TRACHEOTOMY¿ WHICH ¿PROBABLY MADE IT DIFFICULT FOR THE PATIENT TO RECEIVE REHABILITATION.¿ IT WAS FURTHER NOTED THAT THESE WERE ¿SEVERE¿ HEALTH HAZARDS TO THE PATIENT. THE PATIENT WAS REPORTED TO HAVE RECEIVED HOSPITAL ADMISSION AS A RESULT OF SURGERY ¿AFTER-EFFECTS.¿ ADDITIONAL INFORMATION STATED THAT AS OF 13 DAYS AFTER INITIAL REPORT, THE PATIENT HAD ¿NOT RECOVERED¿ SINCE THE EVENT. A SUPPLEMENTAL REPORT WILL BE FILED IF ADDITIONAL INFORMATION IS RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    388674 UNKNOWN IMPLANTABLE NEUROSTIMULATOR STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC NEUROMODULATION NEU_INS_STIMULATOR

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| O| R