BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SOLETRA

    MDR report key: 3884301 · Received June 19, 2014

    Report

    Report Number
    3007566237-2014-01722
    Event Type
    Injury
    Date Received
    June 19, 2014
    Report Date
    June 3, 2014
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TU
    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. 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 PATIENT INFORMATION AND ADDITIONAL INFORMATION REGARDING THE REPORTED EVENT. CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID NEU_UNKNOWN_LEAD, LOT# UNKNOWN, PRODUCT TYPE: LEAD. (B)(4).

    Description of Event or Problem · 1

    SOLMAZ, B., TATARLI, N., CEYLAN, D., BAYRI, Y., ZIYAL, M.I., SEKER, A. A SINE-WAVE-SHAPED SKIN INCISION FOR INSERTING DEEP-BRAIN STIMULATORS. ACTA NEUROCHIRURGICA. 2014. DOI 10.1007/S00701-014-2123-8. SUMMARY: THE SINE-WAVE-SHAPED SKIN INCISION IS A TECHNIQUE THAT MINIMIZES SKIN-RELATED COMPLICATIONS NEAR BURR HOLE CAPS AFTER ELECTRODE PLACEMENT FOR DEEP-BRAIN STIMULATION (DBS). BETWEEN 2011 AND 2013, 54 DBS ELECTRODES WERE IMPLANTED IN 27 CONSECUTIVE PATIENTS WITH PARKINSON¿S DISEASE (PD), ESSENTIAL TREMOR, OR DYSTONIA. THE SINE-WAVE INCISION WAS USED IN 26 PATIENTS AND CONVENTIONAL BILATERAL LINEAR SCALP INCISIONS WERE USED IN ONE PATIENT. NONE OF THE PATIENTS WHOSE OPERATIONS INVOLVED SINEWAVE-SHAPED INCISIONS DEVELOPED HARDWARE-LINKED COMPLICATIONS SUCH AS SKIN INFECTION OR SKIN EROSION. THE ONE PATIENT WHO UNDERWENT CONVENTIONAL BILATERAL LINEAR SCALP INCISIONS DEVELOPED A SKIN INFECTION. BY PRESERVING THE VASCULAR ANATOMY OF THE SCALP AND REDUCING SKIN TENSION AT THE WOUND SITE, THE SINE-WAVE SHAPED INCISION PROMOTES WOUND HEALING. REPORTED EVENT: 1 PATIENT DEVELOPED A SKIN INFECTION AFTER DEEP BRAIN STIMULATION (DBS) IMPLANT. THE REPORTER STATED THAT THE PATIENT HAD UNDERGONE CONVENTIONAL BILATERAL, LINEAR SKIN INCISIONS ON THE SCALP. THE SOURCE LITERATURE INCLUDED THE FOLLOWING DEVICE SPECIFICS: SOLETRA MODEL 7426 FURTHER INFORMATION HAS BEEN REQUESTED; A SUPPLEMENTAL REPORT WILL BE SUBMITTED IF ADDITIONAL INFORMATION IS RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    360078 SOLETRA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC NEUROMODULATION 7426 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 00058 YR Required Intervention