BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SOLETRA

    MDR report key: 1443473 · Received August 12, 2009

    Report

    Report Number
    3004209178-2009-05610
    Event Type
    Injury
    Date Received
    August 12, 2009
    Date of Event
    July 10, 2009
    Report Date
    July 15, 2009
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    NEUROSTIMULATOR MODEL 7426 SERIAL# (B)(4) IMPLANTED: (B)(6) 2009 EXPLANTED: (B)(6) 2010; EXTENSION MODEL 7482 SERIAL# (B)(4) IMPLANTED: (B)(6) 2003 EXPLANTED: (B)(6) 2010; EXTENSION MODEL 7482 SERIAL# (B)(4) IMPLANTED: (B)(6) 2003 EXPLANTED: (B)(6) 2010; LEAD MODEL 3387S LOT# V245950 IMPLANTED: (B)(6) 2009 EXPLANTED: (B)(6) 2010 LEAD MODEL 3387S LOT# V245950 IMPLANTED: (B)(6) 2009 EXPLANTED: (B)(6) 2010; PROGRAMMER MODEL UNKNOWN SERIAL# UNKNOWN.

    Description of Event or Problem · 1

    THE PT WENT TO THE ER BECAUSE OF PAIN AT THE CONNECTOR SITE (ABOVE THE LEFT EAR). IN 2009, THE PT SAW HIS PHYSICIAN AND WAS GIVEN CORTISONE TO PUT ON THE CONNECTOR SITE. IT WAS NOTED THAT WHEN THE PROGRAMMER TURNED THE IMPLANTABLE NEUROSTIMULATOR ON TO DO PROGRAMMING, THE PT RECEIVED A JOLT AND IT STARTED TO HURT HEAD. THE NEXT DAY, THEY SHAVED THE PT'S HEAD AND NOTICED ABOVE THE INCISION THAT THERE WAS A "HUGE BUMP" THAT WAS VERY TENDER TO THE TOUCH. THE PT ALSO HAS SCABS "AS IF IT WAS LEAKING OR BLOOD" AROUND THE CONNECTOR INCISION. THE PT'S WIRE STATED THAT THE SWELLING LOOKED LIKE A "WISH BONE" SHAPE. IT WAS NOTED THAT THE PHYSICIAN DID NOT SEE THE SWELLING THE DAY BEFORE BECAUSE AT THE TIME, THE PT DID NOT HAVE HIS HAIR CUT. THE PT'S NECK WAS ALSO HURTING HIM. THERE WAS NO KNOWN ACCIDENT OR INCIDENT RELATED TO THE EVENT. THE PT WAS PUT ON AN ANTIBIOTIC FOR 20 DAYS. THE PT WAS AT HOME AND HIS STATUS WAS REPORTED TO BE "FAIR". ADD'L INFO HAS BEEN REQUESTED, A FOLLOW-UP REPORT WILL BE SENT IF ADD'L INFO BECOMES AVAILABLE.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT THREE MONTHS AFTER IMPLANT, THE PATIENT FELT AN ELECTRICAL SHOCK. HE WENT TO THE EMERGENCY ROOM, BUT NO ACTION WAS TAKEN. EVENTUALLY THE PATIENT'S ENTIRE SYSTEM WAS REPLACED. IT WAS REPORTED THAT THE DOCTOR TOLD HIM ONE OF THE LEADS HAD EROSION AS A RESULT OF THE PATIENT BEING IN A WHEELCHAIR, AND THE PLASTIC COVERING ON THE LEAD WAS MISSING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SOLETRA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC PUERTO RICO OPERATIONS CO. 7426 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 37 YR Required Intervention LEAD: MODEL 3387S| EXPLANTED:| IMPLANTED:| EXTENSION: MODEL 7482| EXPLANTED:| IMPLANTABLE NEURO STIMULATOR: MODEL 7426| PROGRAMMER: MODEL PROGRAMMER| EXPLANTED:| IMPLANTED:| LEAD: MODEL 3387S| IMPLANTED:| EXTENSION: MODEL 7482| LOT# NFW153656H| IMPLANTED:| IMPLANTED:| EXPLANTED:| EXPLANTED: