BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACTIVA

    MDR report key: 2390724 · Received December 28, 2011

    Report

    Report Number
    3007566237-2011-09362
    Event Type
    Injury
    Date Received
    December 28, 2011
    Report Date
    December 1, 2011
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CONTINUATION OF CONCOMITANT MEDICAL PRODUCTS: UNK IMPLANTED: UNK EXPLANTED: UNK; LEAD MODEL NEU_UNKNOWN_LEAD LOT# UNKNOWN SERIAL# UNK IMPLANTED: UNK EXPLANTED: UNK; LEAD MODEL NEU_UNKNOWN_EXT LOT# UNK SERIAL# UNKNOWN IMPLANTED: UNK EXPLANTED: UNK; LEAD MODEL NEU_UNKNOWN_EXT LOT# UNK SERIAL# UNKNOWN IMPLANTED: UNK EXPLANTED: UNK.

    Description of Event or Problem · 1

    LITERATURE: PIACENTINO, M., PILLERI, M., BARTOLOMEI, L. HARDWARE-RELATED INFECTIONS AFTER DEEP BRAIN STIMULATION SURGERY: REVIEW OF INCIDENCE, SEVERITY AND MANAGEMENT IN 212 SINGLE-CENTER PROCEDURES IN THE FIRST YEAR AFTER IMPLANTATION. ACTA NEUROCHIR (WIEN). 2011;153(12):2337-2341. PUBLISHED ONLINE AUGUST 27, 2011. DOI 10.1007/S00701-011-1130-2. SUMMARY: THE PURPOSE OF THIS STUDY WAS TO EVALUATE RETROSPECTIVELY THE INCIDENCE, SEVERITY AND MANAGEMENT OF DEVICE-RELATED INFECTIONS IN DEEP BRAIN STIMULATION (DBS) PROCEDURES. THE AUTHORS REVIEWED DATA ON 106 PATIENTS IN WHOM 212 PROCEDURES WERE PERFORMED BETWEEN 2001 AND 2011 TO ASSESS INFECTION IN THE FIRST YEAR AFTER IMPLANTATION OF A DBS SYSTEM. ALL PATIENTS UNDERWENT TWO-STAGE SURGERY IN WHICH THE LEADS WERE IMPLANTED FIRST AND THE IMPLANTABLE PULSE GENERATOR (IPG) AND EXTENSIONS WERE IMPLANTED A WEEK LATER. ONLY DEEP INFECTIONS WERE CONSIDERED WHICH WAS DEFINED AS INFECTION THAT EXTENDED INTO THE SUBCUTANEOUS LAYER AND WAS USUALLY IN CONTACT WITH AT LEAST ONE PART OF THE DBS SYSTEM. INFECTIONS OCCURRED ON AVERAGE 30.7 DAYS AFTER BILATERAL LEAD IMPLANT IN NINE PARKINSON'S DISEASE (PD) PATIENTS. ALL INFECTIONS REQUIRED FURTHER SURGERY. REPORTED EVENT: A (B)(6) MALE WITH PD WHO ALSO SUFFERED FROM EXFOLIATIVE DERMATITIS EXPERIENCED SUPPURATIVE INFECTION EITHER AT THE IPG OR THE CONNECTOR SITE 45 DAYS AFTER IMPLANT. A CULTURE WAS POSITIVE FOR (B)(6). THE PATIENT UNDERWENT EXPLANT OF THE IPG AND EXTENSIONS AND WAS TREATED WITH ANTIBIOTICS FOR 4 WEEKS. THE LEADS WERE NOT EXPLANTED. AN IPG AND EXTENSIONS WERE RE-IMPLANTED 3 MONTHS LATER. SEE LITERATURE ARTICLE ATTACHED IN MFR REPORT# 3007566237-2011-09360.

    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 LEAD MODEL NEU_UNKNOWN_LEAD LOT# UNKNOWN SERIAL#