BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 5261243 · Received December 2, 2015

    Report

    Report Number
    3004209178-2015-23666
    Event Type
    Injury
    Date Received
    December 2, 2015
    Date of Event
    October 31, 2015
    Report Date
    November 9, 2015
    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
    IL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID: 8711, SERIAL# (B)(4), IMPLANTED: (B)(6) 2009, PRODUCT TYPE: CATHETER. PRODUCT ID: 8590-1, LOT# N210439, IMPLANTED: (B)(6) 2009, PRODUCT TYPE: ACCESSORY. (B)(4).

    Description of Event or Problem · 1

    INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER (HCP) AND A COMPANY REPRESENTATIVE REGARDING A PATIENT RECEIVING INTRATHECAL GABLOFEN (CONCENTRATION 2000MCG/ML; DOSE 776.4MCG/DAY; LOT 2138-106) VIA AN IMPLANTABLE INFUSION PUMP. THE START DATE OF THE THERAPY WAS (B)(6) 2015 AND WAS ONGOING. INDICATION FOR USE WAS INTRACTABLE SPASTICITY AND SPINAL CORD INJURY/SPINAL CORD DISEASE. MEDICAL HISTORY INCLUDED PARAPLEGIA, PARTIAL PARALYSIS OF BOTH LOWER LIMBS, SUBLUXATION, NEUROGENIC BOWEL, NEUROGENIC BLADDER, AND THORACIC ANEURYSM (RUPTURED). SURGICAL HISTORY INCLUDED CORONARY ANGIOPLASTY WITH STENT PLACEMENT, BACK SURGERY, AND THORACIC AORTA GRAFT ON (B)(6) 2008. ALLERGIES INCLUDED LORAZEPAM. ADDITIONAL PATIENT MEDICATIONS INCLUDED B COMPLEX WITH C, CLOPIDOGREL, DARIFENACIN, DIAZEPAM, ESOMEPRAZOLE, PREGABALIN, AND SILDENAFIL CITRATE. MULTIPLE PUMP MOTOR STALLS AND RECOVERIES WERE RECORDED. THE PATIENT HAD MAGNETIC RESONANCE IMAGING (MRI) PERFORMED ON (B)(6) 2015 AND A PUMP MOTOR STALL OCCURRED AT 15:59 WITH RECOVERY AT 16:34 AS EXPECTED. HOWEVER, WHEN THE HCP REVIEWED THE PUMP LOGS ON (B)(6) 2015 DURING PUMP REFILL, SEVERAL OTHER STALLS AND RECOVERIES WERE NOTED. MOTOR STALL OCCURRED (B)(6) 2015 AT 11:16 WITH RECOVERY AT 17:07, ON (B)(6) 2015 AT 22:31 WITH RECOVERY ON (B)(6) 2015 AT 08:46, AND AGAIN ON (B)(6) 2015 AT 18:02 WITH RECOVERY AT 23:33. THE PATIENT HAD NOT HAD MRI'S ON THESE DAYS AND THERE WAS NO OTHER KNOWN SOURCE OF ELECTROMAGNETIC INTERFERENCE (EMI). IT WAS NOTED THAT THE PATIENT'S PUMP WAS NEARING ELECTIVE REPLACEMENT INDICATOR (ERI). NO TROUBLESHOOTING WAS PERFORMED OTHER THAN INTERROGATION OF THE PUMP. NO ACTIONS WERE TAKEN AS THE PUMP HAD SELF-RECOVERED. THERE WERE NO PATIENT SYMPTOMS RELATED TO THE MOTOR STALLS. PUMP REPLACEMENT WAS PENDING FOR (B)(6) 2015. OUTCOME WAS UNAVAILABLE AT THE TIME OF THE REPORT. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT WAS NOT AVAILABLE AT THE TIME OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    791336 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-20

    Patients

    Seq Age Sex Outcome Treatment
    1 00056 YR Required Intervention