BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN DEEP BRAIN STIMULATOR

    MDR report key: 2120004 · Received June 8, 2011

    Report

    Report Number
    3007566237-2011-04171
    Event Type
    Injury
    Date Received
    June 8, 2011
    Date of Event
    April 1, 2010
    Report Date
    July 14, 2010
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). IT WAS NOT POSSIBLE TO ASCERTAIN SPECIFIC DEVICE INFO FROM THE ARTICLE OR TO MATCH THE EVENTS REPORTED WITH PREVIOUSLY REPORTED EVENTS. ADDITIONAL INFO HAS BEEN REQUESTED. A COPY OF THIS ARTICLE CAN BE OBTAINED AT WWW.KARGER.COM/SFN. DOI: 10.1159/000303528.

    Description of Event or Problem · 1

    LITERATURE: BHATIA S, ZHANG K, OH M, ANGLE C, WHITING D. INFECTIONS AND HARDWARE SALVAGE AFTER DEEP BRAIN STIMULATION SURGERY: A SINGLE-CENTER STUDY AND REVIEW OF THE LITERATURE. STEREOTACT FUNCT NEUROSURG. 2010;88(3):147-155. SUMMARY: THIS ARTICLE DESCRIBED THE INCIDENCE AND MANAGEMENT OF INFECTIONS IN PTS WHO RECEIVED DEEP BRAIN STIMULATION (DBS) BETWEEN (B)(6) 1997 AND (B)(6) 2008 IN A SINGLE INSTITUTION OVER THE PAST 11 YEARS. A DATABASE OF 270 PTS WITH 484 IMPLANTS WAS USED, WITH 56 UNILATERAL AND 214 BILATERAL IMPLANTS. ALL PTS WERE FOLLOWED-UP FOR AT LEAST 6 MONTHS. INFECTION WAS DIAGNOSED BY EITHER ADEQUATE CLINICAL OR POSITIVE MICROBIOLOGICAL EVIDENCE. INCIDENCE, CLINICAL CHARACTERISTICS AND MANAGEMENT OF INFECTIONS WERE ANALYZED. THE OVERALL INFECTION RATE WAS FOUND TO BE 9.3% BY PTS (N=25) AND 6.8% BY EPISODE/IMPLANTS (N=33). THE MEDIAN TIME OF INFECTION AFTER IMPLANT WAS 64 DAYS. COMORBIDITIES WERE MORE FREQUENT IN INFECTED PTS. INFECTION RATES DECREASED FROM 14.3% TO 4.9% AFTER (B)(6) 2003 WHEN THE SURGEONS BEGAN USING A LOW PROFILE BURR HOLE CAP AND EXTENSION AND, DURING THE SECOND STAGE OF THE SURGERY, STARTED TUNNELING IN A MANNER THAT ALLOWED CONNECTION OF THE EXTENSION WIRE TO THE LEAD WITHOUT REOPENING THE PREVIOUS FRONTAL INCISION. OVERALL THERE WERE 19 FRONTAL BURR HOLE, 11 CONNECTOR SITE AND 14 IPG SITE INFECTIONS. CHRONIC SKIN EROSION WAS THE CHIEF CAUSE OF HARDWARE-RELATED INFECTION. REPORTABLE EVENT: A (B)(6) FEMALE, PT, WITH CEREBELLAR TREMOR, CEREBELLAR DEGENERATION, AND PEPTIC ULCER DISEASE EXPERIENCED A DEEP INFECTION WITH PURULENT DRAINAGE IN THE RIGHT FRONTAL BURR HOLE INCISION 22 DAYS AFTER IMPLANT. A CULTURE CAME BACK POSITIVE FOR (B)(6) AND (B)(6). THE PT UNDERWENT INCISION AND DEBRIDEMENT WITH RIGHT LEAD REMOVAL AND WAS TREATED WITH INTRAVENOUS ANTIBIOTICS. ANTIBIOTICS WERE CONTINUED FOR AT LEAST 6 WEEKS. A WEEKLY F/U WAS UNDERTAKEN WITH EXAMINATION OF THE WOUND UNTIL IT WAS COMPLETELY HEALED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNKNOWN DEEP BRAIN STIMULATOR MHY MEDTRONIC NEUROMODULATION UNK NA

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Required Intervention EXPLANTED:| IMPLANTED:| IMPLANTED:| LEAD: MODEL UNK, LOT# UNK| LEAD: MODEL LEADMVD, LOT# UNK| IMPLANTABLE PULSE GENERATOR: MODEL UNK, LOT# UNK| EXPLANTED:| IMPLANTED:| IMPLANTED:| EXPLANTED:| IMPLANTED:| EXTENSION: MODEL UNK, LOT# UNK| EXPLANTED:| EXPLANTED:| EXTENSION: MODEL UNK, LOT# UNK