BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED UNKNOWN

    MDR report key: 2162057 · Received July 12, 2011

    Report

    Report Number
    3007566237-2011-05344
    Event Type
    Injury
    Date Received
    July 12, 2011
    Date of Event
    May 1, 2010
    Report Date
    June 21, 2011
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, 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. AT THIS TIME NO ADDITIONAL INFO WAS AVAILABLE, ADDITIONAL INFO REGARDING THE PATIENT, EVENT, INTERVENTIONS AND OUTCOME HAS BEEN REQUESTED.

    Description of Event or Problem · 1

    LITERATURE: PIRRIS SM, MONACO IEA, TYLER-KABARA EC. TELEMEDICINE THROUGH THE USE OF DIGITAL CELL PHONE TECHNOLOGY IN PEDIATRIC NEUROSURGERY: A CASE SERIES. NEUROSURGERY. MAY 1 2010;66(5):999-1004. SUMMARY: AUTHORS PRESENT A CASE SERIES OF 3 PTS WHO DEVELOPED POSTOPERATIVE WOUND ISSUES THAT WERE ABLE TO BE MANAGED, IN PART, THROUGH DIGITAL CELL PHONE TECHNOLOGY. REPORTABLE EVENT: THE AUTHORS REPORT ON A (B)(6) MALE (PATIENT 3) WHO LIVED > 4 HOURS AWAY FROM THE CHILDREN'S HOSPITAL, HAD AN INTRATHECAL BACLOFEN PUMP FOR THE TREATMENT OF CHOREOATHETOSIS. ONE MONTH POSTOPERATIVELY, HE DEVELOPED SWELLING OVER THE ABDOMINAL PUMP POCKET AND SENT CELL PHONE PICTURES TO THE ATTENDING NEUROSURGEON. AFTER REVIEW OF THE PICTURES, WHICH WERE CONCERNING FOR AN OCCULT CEREBROSPINAL FLUID LEAK AROUND THE INTRATHECAL CATHETER, THE INITIAL TREATMENT RECOMMENDATION WAS BED REST. THE SWELLING RESOLVED WITHIN SEVERAL DAYS. THREE WEEKS LATER, THE PT FELL, STRIKING HIS BACK INCISION. HE THEN DEVELOPED SWELLING OVER THIS LUMBAR INCISION. IMAGES WERE AGAIN TAKEN WITH HIS CELL PHONE AND SENT TO THE ATTENDING NEUROSURGEON. THE PICTURE RAISED CONCERN REGARDING A CONTAINED CEREBROSPINAL FLUID LEAK. THERE WAS NO ERYTHEMA, AND THE PT AND HIS MOTHER DENIED ANY DRAINAGE. THUS, HE WAS INITIALLY MANAGED WITH PRESSURE DRESSINGS, AND THE SWELLING RESOLVED BUT NOT COMPLETELY. ONE WEEK LATER, HE DEVELOPED SYMPTOMS SUGGESTIVE OF BACLOFEN WITHDRAWAL AND WAS INSTRUCTED TO RETURN TO THE NEUROSURGEON IMMEDIATELY. INTRAOPERATIVE EXPLORATION REVEALED THAT HIS INTRATHECAL CATHETER HAD MIGRATED OUT OF THE THECAL SAC.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNCHROMED UNKNOWN LKK MEDTRONIC NEUROMODULATION PUMP NA

    Patients

    Seq Age Sex Outcome Treatment
    1 17 YR Required Intervention EXPLANTED:| IMPLANTED:| CATHETER: MODEL CATHETER, LOT# UNKNOWN