BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SOLETRA

    MDR report key: 2679223 · Received August 2, 2012

    Report

    Report Number
    3007566237-2012-01853
    Event Type
    Injury
    Date Received
    August 2, 2012
    Date of Event
    January 30, 2012
    Report Date
    July 10, 2012
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID NEU_UNKNOWN_LEAD, SERIAL# UNKNOWN, PRODUCT TYPE LEAD. (B)(4). THE ACTUAL EVENT DATES WERE NOT PROVIDED. THIS DATE IS BASED ON THE DATE OF PUBLICATION OF THE ARTICLE. IT WAS NOT POSSIBLE TO ASCERTAIN SPECIFIC DEVICE INFORMATION FROM THE ARTICLE OR TO MATCH THE EVENTS REPORTED WITH PREVIOUSLY REPORTED EVENTS.

    Description of Event or Problem · 1

    LITERATURE: FENOY, A. J., SIMPSON, R. K., JR. MANAGEMENT OF DEVICE-RELATED WOUND COMPLICATIONS IN DEEP BRAIN STIMULATION SURGERY. JOURNAL OF NEUROSURGERY. 2012;116(6):1324-1332. DOI: 10.3171/2012.1. (B)(4). SUMMARY: THE AUTHORS REVIEWED THE INCIDENCE AND MANAGEMENT OF ALL HARDWARE-RELATED WOUND DEHISCENCES AND INFECTIONS IN A LARGE PATIENT SERIES. ALL PATIENTS UNDERGOING NEW DBS HARDWARE IMPLANTATION SURGERY BETWEEN 2002 AND 2010 BY A SINGLE SURGEON (B)(6) WERE ENTERED INTO A DATABASE AFTER UNDERGOING VERIFICATION BY CROSS-REFERENCING MANUFACTURER IMPLANTATION RECORDS. ALL HARDWARE-RELATED COMPLICATIONS SUCH AS WOUND DEHISCENCE, EROSIONS, AND/OR INFECTIONS WERE IDENTIFIED, AND WOUND LOCATION, TIME OF INCIDENCE, AND MECHANISM WERE CATEGORIZED. CHARTS WERE REVIEWED TO EVALUATE THE SUCCESS OF CONSERVATIVE TREATMENT VERSUS PARTIAL OR TOTAL HARDWARE REMOVAL. SEVEN HUNDRED TWENTY-EIGHT PATIENTS RECEIVED 1333 NEW DBS LEADS AND 1218 NEW IMPLANTABLE PULSE GENERATORS (IPGS) IN A TOTAL OF 1356 STEREOTACTIC PROCEDURES FOR MOVEMENT DISORDERS. SEVENTY-EIGHT PERCENT OF PATIENTS UNDERWENT STAGED LEAD AND IPG IMPLANTATIONS. SIXTEEN PATIENTS PRESENTED WITH ATRAUMATIC DEVICE-RELATED INFECTION AND/OR DEHISCENCE WITHIN 12 MONTHS FROM ORIGINAL IMPLANTATION; 9 OF THESE PATIENTS (1.24%) REQUIRED ADDITIONAL SURGERY AFTER ANTIBIOTIC FAILURE. ALL 8 PATIENTS PRESENTING WITH CRANIAL WOUND COMPLICATIONS WERE TREATED INITIALLY BY DEBRIDEMENT IN AN ATTEMPT TO SALVAGE THE LEADS; DEBRIDEMENT FOLLOWED BY INTRAVENOUS ANTIBIOTICS WAS ONLY SUCCESSFUL IN 2 PATIENTS PRESENTING WITH DEHISCENCE ALONE. ONE OF 2 LEAD-ONLY REMOVALS WAS SUCCESSFUL IN INFECTIONS ORIGINATING IN THE CRANIUM; THE ONLY IPG-ORIGINATING INFECTION WAS TREATED BY PARTIAL HARDWARE REMOVAL AND INTRAVENOUS ANTIBIOTICS. TWO OF 637 IPG REPLACEMENTS RESULTED IN INFECTIONS WITHIN 12 MONTHS AFTER REVISION, REQUIRING EITHER PARTIAL OR TOTAL HARDWARE REMOVAL, WHILE 1 DEHISCENCE IN THIS GROUP WAS TREATED BY DEBRIDEMENT ALONE. IN A LARGE SERIES OF NEW DBS HARDWARE IMPLANTATIONS, THE INCIDENCE OF POSTOPERATIVE WOUND DEHISCENCE AND/OR INFECTIONS REQUIRING FURTHER SURGERY WAS 1.24%. STANDARD PRACTICE FOR ALL IMPLANTATIONS WAS A SHORT PROCEDURAL DURATION, COPIOUS POVIDONE-IODINE IRRIGATION, AND POSTOPERATIVE ANTIBIOTIC ADMINISTRATION. PARTIAL HARDWARE REMOVAL SHOULD BE INITIALLY ATTEMPTED FOR INFECTION. DEBRIDEMENT ALONE IS SUCCESSFUL IN TREATING DEHISCENCE WITHOUT INFECTION. REPORTED EVENT: A (B)(6) MALE PATIENT WITH PARKINSON'S DISEASE PRESENTED WITH REDNESS AT THE INCISION 12 DAYS POST-REVISION. CEPHALEXIN WAS PRESCRIBED, AND THE INFECTION CLEARED AND ANTIBIOTICS WERE DISCONTINUED 19 DAYS POST-IMPLANT. NO FURTHER INTERVENTIONS WERE REQUIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SOLETRA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC NEUROMODULATION 7426

    Patients

    Seq Age Sex Outcome Treatment
    1 00047 YR Required Intervention