BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACTIVA

    MDR report key: 2444172 · Received February 9, 2012

    Report

    Report Number
    3007566237-2012-00279
    Event Type
    Injury
    Date Received
    February 9, 2012
    Date of Event
    August 26, 2010
    Report Date
    January 11, 2012
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    IMPLANTED: UNK EXPLANTED: UNK. THE ACTUAL EVENT DATES WERE NOT PROVIDED. IT WAS NOT POSSIBLE TO MATCH THESE EVENTS WITH PREVIOUSLY REPORTED EVENTS. (B)(4).

    Description of Event or Problem · 1

    LITERATURE: DOSHI, PARESH K. "LONG-TERM SURGICAL AND HARDWARE-RELATED COMPLICATIONS OF DEEP BRAIN STIMULATION." STEREOTACTIC AND FUNCTIONAL NEUROSURGERY 89.2 (2011): 89-95. PRINT. SUMMARY: THE AUTHOR EVALUATES THE INCIDENCE OF SURGICAL AND HARDWARE-ASSOCIATED COMPLICATIONS OF DEEP BRAIN STIMULATION (DBS) FOR A RANGE OF MOVEMENT DISORDERS. THIS STUDY IS A RETROSPECTIVE ANALYSIS AND REVIEW OF 153 CASES OF DBS OVER A MINIMUM FOLLOW-UP PERIOD OF 1 YEAR. ONE (B)(6) PATIENT ASPIRATED DURING A STATE OF CONFUSION AND HAD A PROTRACTED RECOVERY. HE DID NOT GET OPERATED AS THE RELATIVES WERE RELUCTANT TO TAKE A SECOND CHANCE. ONE FEMALE EXPERIENCED INTRACEREBRAL HEMORRHAGE ALONG THE ELECTRODE TRACT DURING PHYSIOLOGICAL EXPLORATION. SHE DEVELOPED CONTRALATERAL WEAKNESS OF THE UPPER LIMB. SHE HAD A CARDIAC PACEMAKER IN SITU FOR ARRHYTHMIAS AND HAD ASSOCIATED HYPERTENSION. SHE RECOVERED WITHOUT PERMANENT MORBIDITY. ONE (B)(6) FEMALE DEVELOPED UNCONTROLLED HYPERTENSION WITH SECONDARY HEMORRHAGE NEAR THE ELECTRODE CONTACT POINT 12 HOURS POST- OPERATIVELY. THE PATIENT WAS LEFT WITH HEMIPARESIS. THE LEAD WAS NOT ACCURATELY POSITIONED IN TWO PATIENTS. BOTH PATIENTS OPTED FOR REPOSITIONING OF THE LEADS. REASONS FOR INACCURATE LEAD PLACEMENT INCLUDED PNEUMOCEPHALUS RESULTING IN BRAIN SHIFT, INTRA-OPERATIVE CONFUSION, AND A CAUSE THAT COULD NOT BE IDENTIFIED. THE MISPLACED LEADS WERE OFF BY LESS THAN 2 MM IN AP OR LATERAL DIRECTIONS, PRODUCING SUBOPTIMAL RESPONSE AND/OR LIMITING INCREASE OF STIMULATION (EVEN IN THE BIPOLAR MODE) DUE TO SIDE EFFECTS. ONE PATIENT HAD A WOUND BREAKDOWN OVER THE CONNECTOR SITE IN THE IMMEDIATE POSTOPERATIVE PERIOD LEADING TO INFECTION. THIS INCIDENT NECESSITATED EXPLANTATION OF THE ENTIRE SYSTEM. REPORTED EVENT: ONE PATIENT AFFECTED BY DYSTONIA OPENED UP HIS CHEST WOUND, CAUSING INFECTION THAT LED TO SYSTEM EXPLANTATION. A DYSTONIA PATIENT WHO CAME FROM A VERY POOR SOCIOECONOMIC BACKGROUND IGNORED A SKIN INFECTION OVER THE SCALP WOUND WHICH LED TO PUS FORMATION AND RESULTED IN EXPLANTATION OF THE SYSTEM. THIS OCCURRED TWO YEARS AFTER THE SURGERY. TWO PATIENTS DEVELOPED AN INFECTION OVER THE IPG SITE THAT WAS TREATED BY EXPLANTING THE IPG, TREATING THE INFECTION WITH ANTIBIOTICS, AND RE-IMPLANTING IPG ON THE OTHER SIDE OF THE CHEST WALL ONCE THE INFECTION WAS CONTROLLED. TWO PATIENTS, WITH AN INFECTION OVER THE IPG SITE, WERE MANAGED CONSERVATIVELY. ONE PATIENT DEVELOPED ACUTE STRIDOR AFTER UNILATERAL ELECTRODE IMPLANTATION. THE SURGERY HAD TO BE ABANDONED AND THE OTHER SIDE WAS OPERATED 2 WEEKS LATER. FURTHER INFORMATION IS BEING REQUESTED; A FOLLOW-UP REPORT WILL BE SENT IF ADDITIONAL INFORMATION IS RECEIVED.

    Description of Event or Problem · 1

    TWO PATIENTS EXPERIENCED MALFUNCTION OF IPG. THIS WAS MANIFESTED BY A SUDDEN LOSS OF IMPROVEMENT. ON INTERROGATING THE IPG, IT WAS FOUND TO HAVE RESET. THIS COULD NOT BE FURTHER REPROGRAMMED AND HAD TO BE CHANGED. BOTH INCIDENCES OCCURRED BETWEEN 1 AND 2 YEARS OF DBS IN PARKINSON'S DISEASE PATIENTS IN THE ABSENCE OF VERY HIGH STIMULATOR SETTINGS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACTIVA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC NEUROMODULATION NEU_INS_STIMULATOR

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention| S LEAD MODEL NEU_UNKNOWN_LEAD LOT# UNK SERIAL# UNK