BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 3201293 · Received July 2, 2013

    Report

    Report Number
    3004209178-2013-04765
    Event Type
    Injury
    Date Received
    July 2, 2013
    Report Date
    November 21, 2011
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ND, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 8731SC, SERIAL# (B)(4), IMPLANTED: (B)(6) 2011, EXPLANTED: (B)(6) 2011. PRODUCT TYPE: CATHETER: PRODUCT ID 8731SC, SERIAL# (B)(4), IMPLANTED: (B)(6) 2011, EXPLANTED: (B)(6) 2011. PRODUCT TYPE: CATHETER. (B)(4). ANALYSIS OF THE PUMP FOUND NO ANOMALIES. ANALYSIS OF THE CATHETER FOUND NO SIGNIFICANT ANOMALIES BUT DID NOTE DAMAGE TO THE SUTURELESS CONNECTOR (SC) CONNECTOR AT EXPLANT.

    Description of Event or Problem · 1

    A PUMP AND CATHETER WERE RETURNED WITH LIMITED INFORMATION. IT WAS REPORTED BOTH THAT THE PATIENT HAD NO INJURY AND RECOVERED WITH SEQUELA. IT WAS ALSO REPORTED THAT THE BATTERY WAS DEPLETED BUT THAT THE DEVICES WERE RETURNED FOR DISPOSAL ONLY. ANALYSIS FOUND THAT THE BATTERY WAS NOT DEPLETED. IT WAS REPORTED THAT NO ROTOR OR DYE STUDY WAS PERFORMED. ADDITIONAL INFORMATION RECEIVED INDICATED THAT THIS PUMP AND CATHETER IMPLANTED IN (B)(6) 2011 ¿WOULDN¿T STAY IN¿ THE PATIENT¿S SPINE. IT WAS REPORTED THAT WHEN THE PHYSICIAN WENT TO TAKE IT OUT THE CATHETER, HE SAID ¿IT LOOKED LIKE IT HAD BEEN--JUST LIKE IT HAD ALMOST BEEN CUT IN HALF--THE CATHETER¿. THE PHYSICIAN SAID ¿IT WAS THE WEIRDEST THING¿ AND HE HAD ¿PUT IN OVER 300 OF THESE AND I'VE NEVER SEEN ANYTHING LIKE IT¿. IT WAS ALSO REPORTED THAT THE PATIENT HAD SEVERE SCOLIOSIS IN HER LUMBAR SPINE, AND THE PHYSICIAN SAID THAT COULD BE THE REASON FOR THE PROBLEM WITH THE CATHETER BUT HE DID NOT KNOW FOR SURE. IT WAS ALSO REPORTED THAT THE PATIENT HAD FUSIONS AND HAD RODS IN HER BACK, AND THE REPORTER SAID THAT PATIENT¿S SPINE ¿WAS BASICALLY COLLAPSING¿. IT WAS REPORTED THAT AFTER THE PATIENT GOT THE PAIN PUMP, THE PATIENT FELT IT JUST DID NOT SEEM LIKE IT WAS HELPING; IT WAS REPORTED THAT THE PATIENT NEVER GOT ANY RELIEF. THEN IT WAS DISCOVERED THE CATHETER ¿WAS NOT IN THERE¿, AND THEY TOOK IT OUT AND PUT IN ANOTHER CATHETER AND THE SAME THING HAPPENED (SEE MANUFACTURER¿S REPORT # 3004209178-2012-02787 FOR THE SECOND CATHETER)]. THE PATIENT JUST NEVER FELT LIKE IT WAS GIVING HER ANYTHING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    303202 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-20

    Patients

    Seq Age Sex Outcome Treatment
    1 00059 YR Required Intervention