BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 1634767 · Received March 17, 2010

    Report

    Report Number
    3004209178-2010-02195
    Event Type
    Injury
    Date Received
    March 17, 2010
    Report Date
    March 28, 2016
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO., JUNCOS
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Removal / Correction Number
    Z-1150-2008
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B) (4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 8590-1, LOT# N185025, IMPLANTED: (B)(6) 2009, EXPLANTED: (B)(6) 2010, PRODUCT TYPE: ACCESSORY. PRODUCT ID 8578, LOT# N193452006, IMPLANTED: (B)(6) 2009, EXPLANTED: (B)(6) 2010, PRODUCT TYPE: ACCESSORY. PRODUCT ID 8840, PRODUCT TYPE: PROGRAMMER, PHYSICIAN. (B)(4).

    Additional Manufacturer Narrative · 1

    A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT IT ¿LEAKED THE SIZE OF SOFTBALL IN STOMACH THAT BLEW UP,¿ AND THAT AT FIRST, A PUMP BLEW UP INSIDE OF THE PATIENT AND "ALL THE CSF FLUID." AFTER THIS PUMP WAS IMPLANTED, AFTER CLOSING, THE HOLE STARTING OPENING UP; THERE WAS INFECTION, AND THE REPORTER COULD SEE THE PUMP IN THE STOMACH TO THE SIDE. THE PATIENT WENT TO AN INFECTIOUS DISEASE DOCTOR AND THEY SAID TO TAKE OUT THE PUMP AND OPERATE. THEY REPORTEDLY CUT A PIECE AWAY WHERE THE HOLE WAS AND SENT AWAY FOR BIOPSY, BUT THE PATIENT NEVER HEARD ANYTHING ABOUT IT.

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT EXPERIENCED ISSUES WITH THE MESH POUCH AND THE CONNECTOR. THE MESH POUCH WAS REMOVED IN 2009 AND 7 WEEKS LATER, THE PATIENT HAD SWELLING, "THE SIZE OF A SOFTBALL", AT THE IMPLANT SITE. THE PATIENT STATED THE INCISION BROKE OPEN. THE HCP INDICATED IT COULD HAVE BEEN "A GERM" - INFECTION. THE PATIENT NOTED HE HAD OTHER IMPLANTED DEVICES SUCH AS "SCREWS" THAT HIS BODY HAD REJECTED IN THE PAST. THE PATIENT HAD THE PUMP AND CATHETER EXPLANTED AROUND (B) (6) 2010. THE PATIENT STATED THAT PART OF THE CATHETER STILL REMAINED IMPLANTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED; A FOLLOW-UP REPORT WILL BE SUBMITTED IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Description of Event or Problem · 1

    THE PATIENT'S PUMP REPORTEDLY 'BLEW UP INSIDE OF THEM'. THEY HAD THREE SURGERIES IN SIX MONTHS (SEE ALSO MANUFACTURER'S REPORT #2182 207-2006-00635 FOR A SIMILAR ISSUE WITH THE PATIENT'S PREVIOUS PUMP). IT SWELLED TO THE SIZE OF A GOLF BALL FILLED WITH CEREBROSPINAL FLUID (CSF), AND THERE WAS A HOLE IN THEM. THE PUMP WAS REMOVED IN (B)(6) 2010. WHEN RETURNED TO THEM, IT HAD A WHITE SUBSTANCE ALL OVER THE PUMP. THE PATIENT MENTIONED THAT WHEN THE PUMP WAS REMOVED, THE PUMP, POUCH, AND DISTAL TIP WERE COVERED IN WHITE GRANULOMAS. THE PATIENT'S CATHETER AND CONNECTORS WERE STILL IN THEIR BODY EVEN THOUGH THE PUMP WAS REMOVED. THE PUMP CONTAINED DILAUDID.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED FROM THE PATIENT REPORTED THAT THE HOLE IN THE "STOMACH" FROM ONE OF THE ADDITIONAL SURGERIES THAT CAUSED ANOTHER SURGERY (LIKELY THE THIRD SURGERY THE PATIENT PREVIOUSLY REFERRED TO). ALSO NOTING THAT THE PUMP COULD NOT BE PLACED IN THERE ANYMORE. THE PATIENT NOTED THERE WAS SOMETHING WITH "THE BOLUS" AND IT WASN'T REGULAR, AND THEY TOOK IT OUT; THEN AGAIN FURTHER SPECIFIED THAT THEY TOOK PICTURES OF THE AREA OF SPINAL FLUID AND OTHER FLUID THAT WAS THE SIZE OF A SOFTBALL AND WAS STICKING OUT OF HIM. INDICATION FOR USE OF THE DEVICE WAS FOR NON-MALIGNANT PAIN AND OTHER NON-MALIGNANT PAIN.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention IMPLANTED:| CATHETER: MODEL 8709, LOT# J11016R50| EXPLANTED:| PROGRAMMER: MODEL 8840, LOT# UNK| CATHETER: MODEL 8578, LOT# N193452006| EXPLANTED:| IMPLANTED:| EXPLANTED:| ACCESSORY: MODEL 8590-1, LOT# N185025| IMPLANTED: