BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNERGY VERSITREL

    MDR report key: 3476381 · Received November 19, 2013

    Report

    Report Number
    3004209178-2013-21021
    Event Type
    Injury
    Date Received
    November 19, 2013
    Report Date
    April 30, 2013
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT SUMMARY #REVIEWED AND CONFIRMED / UPDATED RFR, HAZARD, AND CONCLUSION CODES. A GOOD FAITH EFFORT FOR FOLLOW-UP WAS COMPLETED. THE INFORMATION IN THE FILE WAS INSUFFICIENT TO EVALUATE AND INVESTIGATE BECAUSE THE PATIENT REPORTED THAT HER DEVICE PROTRUDES AND IS PAINFUL WHEN SHE RIDES IN THE CAR. HOWEVER, THE HEALTHCARE PROFESSIONAL REPORTED THAT THEY HAD NOT SEEN THIS PATIENT SINCE 2007 AND HAD NO FURTHER INFORMATION ABOUT THIS EVENT. THE PATIENT LETTER WAS RETURNED NOTING EHS HAD NO CONCERNS. THE STATUS OF THE SYNERGY REMAINS UNKNOWN. THE EVENT DID NOT ALLEGE A POTENTIAL MANUFACTURING ISSUE; THEREFORE, A DHR REVIEW WAS NOT REQUIRED FOR THE SYNERGY. THE EVENT WAS REVIEWED FOR PREVIOUS INVESTIGATIONS AND NONE APPLIED. THE EVENT WAS REVIEWED FOR KNOWN INHERENT RISKS LISTED IN PRODUCT LABELING AND NONE WERE NOTED. REVIEWED FOR ESCALATION TO NCET AND ESCALATION WAS NOT REQUIRED. THERE WERE NO REMEDIAL ACTIONS TAKEN AS A RESULT OF THE EVENT. THE INVESTIGATION OF THE SYNERGY IS INCONCLUSIVE BECAUSE OF INSUFFICIENT EVENT INFORMATION. CONCOMITANT PRODUCTS: PRODUCT ID: 7435, SERIAL# UNKNOWN, PRODUCT TYPE: PROGRAMMER, PATIENT. PRODUCT ID: 3998, LOT# J0406547V, IMPLANTED: (B)(6) 2004-03-24, PRODUCT TYPE: LEAD. PRODUCT ID: 748925, SERIAL# (B)(4), IMPLANTED: (B)(6) 2004, PRODUCT TYPE: EXTENSION. PRODUCT ID: 748925, SERIAL# (B)(4), IMPLANTED: (B)(6) 2004, PRODUCT TYPE: EXTENSION. PRODUCT ID: 748925, SERIAL# (B)(4), IMPLANTED: (B)(6) 2004, PRODUCT TYPE: EXTENSION. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT¿S IMPLANTABLE NEUROSTIMULATOR (INS) WAS PROTRUDING FROM THEIR SKIN. IT WAS REPORTED IT WOULD HURT WITH ANYTHING THE PATIENT CAME INTO CONTACT WITH WHICH MADE IT DIFFICULT AND PAINFUL TO SIT IN A CAR. IT WAS NOTED THAT IT WAS ACTUALLY CAUSING MORE PAIN FOR THEM. IT WAS REPORTED THEY OPENED THE POCKET UP TO MAKE IT DEEPER TO WHERE IT WOULD GO IN CLOSER TO THE PATIENT¿S BODY VERSUS PROTRUDING OUT. (B)(6) 2013 LFC (HCP): NO NEW INFORMATION (B)(6) 2013 (B)(4) (CON): ADDITIONAL INFORMATION STATED THE PATIENT ¿DID NOT HAVE CONCERNS ABOUT THEIR DEVICE OR THERAPY¿ AND THAT THEIR ¿CONCERNS WERE RESOLVED THROUGH CUSTOMER SUPPORT.¿

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    598890 SYNERGY VERSITREL STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 7427V

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention