BEUDAMED
    FDA Adverse Event Injury Summary report: N

    KINETRA

    MDR report key: 2120155 · Received June 6, 2011

    Report

    Report Number
    3007566237-2011-03993
    Event Type
    Injury
    Date Received
    June 6, 2011
    Date of Event
    April 13, 2010
    Report Date
    June 11, 2010
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THIS ARTICLE WAS PUBLISHED ONLINE IN WILEY INTERSCIENCE (WWW.INTERSCIENCE.WILEY.COM).

    Description of Event or Problem · 1

    LITERATURE: LOW HL. REPLY: THE 'PLAIT SIGN' OF NEUROSTIMULATOR TORSION. MOV DISORD. MAY 15 2010:25(7)965-966. SUMMARY: THIS ARTICLE DISCUSSES A CASE OF TORSION OF AN IMPLANTABLE NEUROSTIMULATOR (INS) IN THE SUBCUTANEOUS POCKET DUE TO ACCUMULATED FLUID. THE PT WAS A (B)(6) MALE PT WITH SEVERE ESSENTIAL TREMOR IN THE ARMS WHO UNDERWENT BILATERAL POSTERIOR SUBTHALAMIC AREA DEEP BRAIN STIMULATION WITH THE INS INSERTED INTO THE LEFT INFRACLAVICULAR REGION AND SECURED TO THE PECTORALIS FASCIA WITH NYLON SUTURES. EVENT: THREE MONTHS AFTER SURGERY, THE PT EXPERIENCED A SUDDEN WORSENING OF ARM TREMOR BACK TO PRE-SURGICAL LEVELS AND THE INS DID NOT RESPOND TO THE PT PROGRAMMER. THERE WAS MODERATE SIZED SUBCUTANEOUS FLUID COLLECTION OVER THE INS. THE SKIN OVER THE INS WAS SLIGHTLY BRUISED. THE PT NOTICED INCREASED SWELLING AND BRUISING IN THAT AREA A WEEK BEFORE THE TREMOR WORSENED AND ADMITTED THAT THE INS HAD PREVIOUSLY HIT THE EDGE OF THE BED WHILE THE PT TOSSED AND TURNED IN HIS SLEEP. IMPEDANCE READINGS WERE FOUND TO BE >4000 OHMS. X-RAYS DID NOT SHOW ANY LEAD OR EXTENSION FRACTURES, BUT THE EXTENSIONS WERE TWISTED AROUND EACH OTHER AND THE DIRECTION OF THE CONNECTION BETWEEN THE EXTENSIONS AND THE INS WAS OPPOSITE TO THAT EXPECTED FOR ITS POSITION, WHICH SUGGESTED TORSION OF THE INS. EXPLORATION SURGERY WAS PERFORMED DURING WHICH IT WAS FOUND THAT THE POCKET AROUND THE INS WAS DISTENDED AND FILLED WITH APPROXIMATELY 20 ML OF SEROSANGUINOUS FLUID, THE INS HAD ROTATED 180 DEGREES AROUND A PEDICLE FORMED BY THE EXTENSIONS, AND BOTH EXTENSIONS HAD FRACTURED NEAR THE POINT WHERE THEY CONNECTED TO THE INS. THE EXTENSIONS WERE REPLACED AND THE INS WAS REPOSITIONED. THE POCKET SPACE WAS DECREASED BY TIGHTLY STITCHING THE PECTORALIS FASCIA TO THE OVERLYING SUBCUTANEOUS FASCIA WITH NYLON SUTURES. INTRA-OPERATIVE TESTING SHOWED THAT THE DEVICE WAS FUNCTIONING AND THAT THE TEST STIMULATION CONTROLLED THE ARM TREMOR. THERE WAS NO INFECTION. THE PT'S TREMOR CONTROL RETURNED TO OPTIMAL LEVELS. IT WAS NOT POSSIBLE TO ASCERTAIN SPECIFIC DEVICE INFO FROM THE ARTICLE OR TO MATCH THE EVENTS REPORTED WITH PREVIOUSLY REPORTED EVENTS. AT THIS TIME NO ADDITIONAL INFO WAS AVAILABLE. ADDITIONAL INFO HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 KINETRA MHY MEDTRONIC NEUROMODULATION 7428 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Required Intervention LEAD: MODEL UNK, LOT# UNK| EXPLANTED:| EXTENSION: MODEL UNK, LOT# UNK| IMPLANTED:| LEAD: MODEL UNK, LOT# UNK| IMPLANTED:| EXPLANTED:| EXTENSION: MODEL UNK, LOT# UNK| IMPLANTED:| IMPLANTED:| EXPLANTED:| EXPLANTED: