BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INFUSION PUMP

    MDR report key: 5053396 · Received September 3, 2015

    Report

    Report Number
    3007566237-2015-02497
    Event Type
    Injury
    Date Received
    September 3, 2015
    Report Date
    August 6, 2015
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS NOT POSSIBLE TO MATCH THESE EVENTS WITH ANY PREVIOUSLY REPORTED EVENTS. CONCOMITANT PRODUCT: PRODUCT ID: NEU_UNKNOWN_CATH, PRODUCT TYPE: CATHETER. (B)(4). .

    Description of Event or Problem · 1

    ABDULLA, S.,VIELHABER, S., HEINZE, H-J., ABDULLA, W. A NEW APPROACH USING HIGH VOLUME BLOOD PATCH FOR PREVENTION OF POST-DURAL PUNCTURE HEADACHE FOLLOWING INTRATHECAL CATHETER PUMP EXCHANGE. INTERNATIONAL JOURNAL OF CRITICAL ILLNESS <(>&<)> INJURY SCIENCE. 2015; 5(2):93-98. DOI: ORG/10.4103/2229-5151.158395 SUMMARY: IN AN OBSERVATIONAL STUDY, COMPLICATIONS OF INTRATHECAL CATHETER PUMPS NECESSITATING SURGICAL EXCHANGE WERE ANALYZED. ALSO THE USE OF A HIGH-VOLUME PROPHYLACTIC EPIDURAL BLOOD PATCH (EBP) DURING SURGERY FOR PREVENTING POST-DURAL PUNCTURE HEADACHE (PDPH) WITH A FOLLOW-UP FOR 1 YEAR IS DESCRIBED. IN 22 PATIENTS WITH REFRACTORY CHRONIC PAIN OF CANCER/NON CANCER ORIGIN OR SEVERE SPASTICITY, WHO WERE RECEIVING INTRATHECAL MORPHINE INCLUDING ADJUVANTS OR BACLOFEN FOR SYMPTOM RELIEF, CATHETER EXCHANGE WITH OR WITHOUT PUMP WAS PERFORMED. IN PATIENTS WITH DOCUMENTED SYMPTOMS OF PDPH FOLLOWING INITIAL INTRATHECAL CATHETER IMPLANTATION, A PROPHYLACTIC EBP WITH A HIGH BLOOD VOLUME WAS USED FOR PDPH PREVENTION DURING SURGERY. CATHETERS WERE REPLACED USING 40 ML EBP BEFORE ENTERING DURAL SPACE AT A SPEED OF 5ML/MIN INTO THE EPIDURAL SPACE. PATIENTS WERE ASKED TO QUANTIFY PAIN EXPERIENCE AND FUNCTIONAL ABILITY. FROM A SAMPLE OF 72 PATIENTS ADMITTED FOR CATHETER EXCHANGE WITH OR WITHOUT PUMP, 22 PATIENTS (33%) (12 MALE, 10 FEMALE) HAD A HISTORY OF PDPH FOLLOWING INITIAL IMPLANTATION. DIAGNOSTIC AND THERAPEUTIC MEASURES OCCURRING WITH MALFUNCTION OF INTRATHECAL CATHETER PUMP SYSTEMS WERE DESCRIBED. TWENTY-ONE PATIENTS WERE SUCCESSFULLY TREATED WITH PROPHYLACTIC EBP, WHILE ONE PATIENT COULD NOT BE PROPERLY EVALUATED BECAUSE OF INTRACRANIAL BLEEDING AS THE UNDERLYING DISEASE. A NEW APPROACH USING A HIGH-VOLUME PROPHYLACTIC EBP FOR PREVENTING PDPH FOLLOWING CATHETER EXCHANGE IS PRESENTED. THE EFFICACY AND SAFETY OF THIS TECHNIQUE FOR 1 YEAR FOLLOW-UP HAVE BEEN EVALUATED AND WAS FOUND TO BE SAFE AND POTENTIALLY EFFECTIVE. REPORTED EVENTS: FIFTY PATIENTS WERE ADMITTED FOR CATHETER EXCHANGE WITH OR WITHOUT EXCHANGE OF THE PUMP. THERE HAD BEEN A DISTINCT INCREASE OF PREDOMINANTLY EXCITATORY SYMPTOMS (HYPEREXCITABILITY OR INCREASED MUSCLE SPASTICITY) DUE TO REDUCED DRUG INFUSION SUGGESTING A MALFUNCTIONING PUMP AND/OR A CATHETER DEFECT. THERE HAD BEEN COMPLICATIONS OF INTRATHECAL CATHETER PUMPS THAT NECESSITATED SURGICAL EXCHANGE: IN FOUR CASES, CATHETER OBSTRUCTION WAS CONFIRMED BY THE LACK OF CEREBROSPINAL FLUID (CSF) ASPIRATION WITH THE NEEDLE INSERTED INTO THE SIDE PORT. NORMAL SALINE WAS ALSO UNABLE TO ENTER THE PORT. IN SEVEN CASES, LEAKAGE OF CSF WITH PERFORATING TEAR WAS FOUND IN CLOSE PROXIMITY TO THE VERTEBRAL SPINOUS PROCESS AND SPINE CATHETER ENTRY SITE. ONE CATHETER WAS CHECKED UNDER FLUOROSCOPY AND SLIGHT LEAKING WAS FOUND AT DIFFERENT SITES IN THE CATHETER SYSTEM. FLUOROSCOPIC IMAGES OF THE CONTRAST DYE SHOWED LEAKING AT THE CATHETER ENTRY SITE INTO THE SPINAL SPACE AND LEAKING IN CLOSE PROXIMITY TO THE PUMP. DURING SURGICAL EXPLORATION AT THE SITE OF SPINAL ENTRY, A FIBROUS SHEATH WAS OBSERVED TO HAVE FRACTURED AND OBSTRUCTED THE CATHETER. SEE ATTACHED LITERATURE ARTICLE IN MANUFACTURER REPORT #3007566237-2015-02487.

    Description of Event or Problem · 1

    THE EVENT DATE, PATIENT IDENTIFICATION, PRODUCT INFORMATION, SYMPTOMS, TROUBLESHOOTING/DIAGNOSTICS PERFORMED, ALLEGED ISSUE, POTENTIAL CAUSES OF THE EVENT, AND OUTCOME WERE NOT REPORTED FOR VARIOUS REPORTED EVENTS. FURTHER FOLLOW-UP WAS BEING REQUESTED TO OBTAIN ADDITIONAL INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    583711 INFUSION PUMP PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MEDTRONIC NEUROMODULATION

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R