BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNERGY

    MDR report key: 1213780 · Received October 22, 2008

    Report

    Report Number
    3004209178-2008-06741
    Event Type
    Malfunction
    Date Received
    October 22, 2008
    Date of Event
    March 1, 2008
    Report Date
    September 24, 2008
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    FOLLOWING A LEAD REVISION (SEE MFR'S REPORT # 3004209178-2008-06213), THE PT REPORTED STIMULATION IN THE WRONG LOCATION. THE PT WAS GETTING STIMULATION IN THE ABDOMEN. IT WAS CAUSING HER TO HAVE BLADDER SPASMS AND IRRITABLE BOWEL SYNDROME. THE STATED THAT IT FELT LIFE A KNIFE AND IT HURT TO BREATH. THE PT'S SYMPTOMS WERE LOCATED IN HER MID-BACK. SHE SAID SHE COULDN'T DRIVE AND GO TO A STORE; SHE WAS GETTING FITTED FOR A WHEELCHAIR. SHE INCLUDED THAT HER HEALTHCARE PROFESSIONAL (HCP) STATED THAT HER PAIN WAS POST LAMINECTOMY SYNDROME; HOWEVER, THE PT DIDN'T BELIEVE THIS BECAUSE IT HURT IN THE MIDDLE OF HER BACK. THE HCP REFERRED THE PT TO ANOTHER HCP WHO SHE SAID WAS A COMPLEX SPINE DOCTOR. THAT HCP OFFERED TO DO A FOUR HOUR SURGERY TO TRY AND FIX THE LEAD, BUT THE PT STATED SHE DID NOT WANT TO DO THAT. SHE INCLUDED THAT SHE WAS SCHEDULED TO DO A PUMP TRIAL IN OCTOBER WITH ANOTHER HCP. THE PT WAS AT HOME. HER STATUS WAS REPORTED TO BE "FAIR". ADD'L INFO HAS BEEN REQUESTED, A FOLLOW-UP REPORT WILL BE SENT IN ADD'L INFO BECOMES AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNERGY LGW MEDTRONIC PUERTO RICO OPERATIONS CO. 7427 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR LEAD: MODEL 3587A| EXTENSION: MODEL 7495-51| IMPLANTED:| PROGRAMMER: MODEL 7439| EXPLANTED:| EXPLANTED: