BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN IMPLANTABLE NEUROSTIMULATOR

    MDR report key: 3955932 · Received July 24, 2014

    Report

    Report Number
    3007566237-2014-02075
    Event Type
    Injury
    Date Received
    July 24, 2014
    Report Date
    July 3, 2014
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THIS VALUE IS THE AVERAGE AGE OF THE PATIENTS REPORTED IN THE ARTICLE AS SPECIFIC PATIENTS COULD NOT BE IDENTIFIED. THIS VALUE REFLECTS THE GENDER OF THE MAJORITY OF THE PATIENTS REPORTED IN THE ARTICLE AS SPECIFIC PATIENTS COULD NOT BE IDENTIFIED. 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, LOT# UNKNOWN PRODUCT TYPE: LEAD. PRODUCT ID NEU_UNKNOWN_LEAD LOT# UNKNOWN SERIAL# IMPLANTED: EXPLANTED: PRODUCT TYPE LEAD. PRODUCT ID: NEU_UNKNOWN_LEAD, PRODUCT TYPE: LEAD. PRODUCT ID: NEU_INS_STIMULATOR, PRODUCT TYPE: IMPLANTABLE NEUROSTIMULATOR. PRODUCT ID: NEU_INS_STIMULATOR, PRODUCT TYPE: IMPLANTABLE NEUROSTIMULATOR. PRODUCT ID: NEU_UNKNOWN_LEAD, PRODUCT TYPE: LEAD. (B)(4).

    Description of Event or Problem · 1

    (B)(6). FACTORS PREDICTING INCREMENTAL ADMINISTRATION OF ANTIHYPERTENSIVE BOLUSES DURING DEEP BRAIN STIMULATOR PLACEMENT FOR PARKINSON'S DISEASE. JOURNAL OF CLINICAL NEUROSCIENCE: OFFICIAL JOURNAL OF THE NEUROSURGICAL SOCIETY OF (B)(6). 0967;2014 JUN 7. DOI 10.1016/J.JOCN.2014.04.005. SUMMARY: HYPERTENSION IS COMMON IN DEEP BRAIN STIMULATOR (DBS) PLACEMENT PREDISPOSING TO INTRACRANIAL HEMORRHAGE. THIS RETROSPECTIVE REVIEW EVALUATES FACTORS PREDICTING INCREMENTAL ANTIHYPERTENSIVE USE INTRAOPERATIVELY. MEDICAL RECORDS OF PARKINSON¿S DISEASE (PD) PATIENTS UNDERGOING DBS PROCEDURE BETWEEN 2008¿2011 WERE REVIEWED AFTER INSTITUTIONAL REVIEW BOARD APPROVAL. ANESTHESIA MEDICATION, PREOPERATIVE LEVODOPA DOSE, AGE, PREOPERATIVE USE OF ANTIHYPERTENSIVE MEDICATIONS, DIABETES MELLITUS, ANXIETY, MOTOR PART OF THE UNIFIED PARKINSON¿S DISEASE RATING SCALE SCORE AND PD DURATION WERE COLLECTED. UNIVARIATE AND MULTIVARIATE ANALYSIS WAS DONE BETWEEN EACH PATIENT CHARACTERISTIC AND THE NUMBER OF ANTIHYPERTENSIVE BOLUSES. FROM THE 136 PATIENTS INCLUDED 60 WERE HYPERTENSIVE, OF WHOM 32 WERE ON ANGIOTENSIN CONVERTING ENZYME INHIBITORS (ACEI) OR ANGIOTENSIN RECEPTOR BLOCKERS (ARB), TOLD TO HOLD ON THE MORNING OF SURGERY. ANTIHYPERTENSIVE MEDICATIONS WERE GIVEN TO 130 PATIENTS INTRAOPERATIVELY. AGE (RELATIVE RISK [RR] 1.01; 95% CONFIDENCE INTERVAL [CI] 1.00¿1.02; P = 0.005), HIGH JOINT NATIONAL COMMITTEE (JNC) CLASS (P <(><<)> 0.0001), DIABETES MELLITUS (RR 1.4; 95%CI 1.2¿17; P <(><<)> 0.0001) AND DURATION OF PD >10 YEARS (RR 1.2; 95%CI 1.1¿1.3; P = 0.001) WERE INDEPENDENT PREDICTORS FOR ANTIHYPERTENSIVE USE. NO DIFFERENCE WAS NOTED IN THE MEAN DOSE OF LEVODOPA (P = 0.1) AND LEVODOPA EQUIVALENT DOSE (P = 0.4) BETWEEN THE LOW (I/II) AND HIGH SEVERITY (III/IV) JNC GROUPS. ADDITION OF DEXMEDETOMIDINE TO PROPOFOL DID NOT INFLUENCE ANTIHYPERTENSIVE BOLUSES REQUIRED (P = 0.38). INTRAOPERATIVE HYPERTENSION DURING DBS SURGERY IS ASSOCIATED WITH HIGHER AGE GROUP, HYPERTENSIVE, DIABETIC PATIENTS AND LONGER DURATION OF PD. WITHHOLDING ACEI OR ARB IS AN INDEPENDENT PREDICTOR OF HYPERTENSION REQUIRING MORE AGGRESSIVE THERAPY. LEVODOPA WITHDRAWAL AND CHOICE OF ANESTHETIC AGENT IS NOT ASSOCIATED WITH HIGHER INTRAOPERATIVE ANTIHYPERTENSIVE MEDICATIONS. REPORTED EVENTS: 1. 1 PATIENT EXPERIENCED AN INTRACRANIAL HEMORRHAGE WHICH WAS SEEN ON A HEAD CT SCAN TAKEN IMMEDIATELY POSTOPERATIVELY. THE REPORTER STATED THAT THE PATIENT HAD AN INTRAPARENCHYMAL HEMORRHAGE. IT WAS NOTED THAT THE MAXIMUM BLOOD PRESSURE WAS 140 MMHG FOR 15 MINUTES. 2. 1 PATIENT EXPERIENCED AN INTRACRANIAL HEMORRHAGE WHICH WAS SEEN ON A HEAD CT SCAN TAKEN IMMEDIATELY POSTOPERATIVELY. THE REPORTER STATED THAT THE PATIENT HAD A SUBDURAL HEMORRHAGE. IT WAS NOTED THAT THE MAXIMUM BLOOD PRESSURE WAS 180 MMHG FOR 20 MINUTES. 3. 5 PATIENTS HAD AN INTRACRANIAL HEMORRHAGE WHICH WAS DISCOVERED DURING THE FIRST 4 WEEKS POSTOPERATIVELY. IT WAS NOTED THAT THESE HEMORRHAGES HAD NOT BEEN PRESENT IN THE IMMEDIATE POST-PROCEDURE CT SCAN. THE REPORTER STATED THAT THESE WERE COUNTED AS NOT RELATED TO THE INTRAOPERATIVE EVENT OR HYPERTENSION. THE SOURCE LITERATURE INCLUDED THE FOLLOWING DEVICE SPECIFICS: LEAD MODEL 3389 OR LEAD MODEL 3387 IMPLANTED IN 136 PATIENTS FURTHER INFORMATION HAS BEEN REQUESTED; A SUPPLEMENTAL REPORT WILL BE SUBMITTED IF ADDITIONAL INFORMATION IS RECEIVED. SEE ATTACHED LITERATURE ARTICLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    433340 UNKNOWN IMPLANTABLE NEUROSTIMULATOR STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC NEUROMODULATION NEU_INS_STIMULATOR UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 00063 YR Other