BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNERGY

    MDR report key: 2770914 · Received October 3, 2012

    Report

    Report Number
    3004209178-2012-08851
    Event Type
    Injury
    Date Received
    October 3, 2012
    Date of Event
    September 7, 2012
    Report Date
    December 11, 2017
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID 748951, SERIAL# (B)(4), IMPLANTED: 2005 (B)(6), PRODUCT TYPE EXTENSION, PRODUCT ID 7435, SERIAL# (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT PRODUCT ID 3550-09, LOT# N0018017, IMPLANTED: 2005 (B)(6), PRODUCT TYPE ACCESSORY, PRODUCT ID 3487A-33, LOT# J0437387V, IMPLANTED: 2005 (B)(6), PRODUCT TYPE LEAD. FOR USE BY USER FACILITY/IMPORTER (DEVICES ONLY). (B)(4).

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT SUMMARY: REVIEWED AND CONFIRMED / UPDATED RFR, HAZARD, CAUSE AND PSC CODES. A GOOD FAITH EFFORT FOR FOLLOW-UP WAS CONDUCTED BUT NO ADDITIONAL INFORMATION WAS OBTAINED. THE INS WAS EXPLANTED, BUT NOT RETURNED. DEVICE RETURN AND ANALYSIS IS NOT NEEDED TO ASSIST IN THE EVALUATION AND INVESTIGATION OF THE EVENT. THE EVENT DID NOT ALLEGE A POTENTIAL MANUFACTURING ISSUE; THEREFORE, A DHR REVIEW WAS NOT REQUIRED. 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. BASED ON THE EVENT INFORMATION, THERE ARE NO ANOMALIES FOUND WITH THE INS AND/OR THERAPY. CONCOMITANT PRODUCTS: PRODUCT ID 3550-09, LOT # N0018017, IMPLANTED: (B)(6) 2005, PRODUCT TYPE ACCESSORY; PRODUCT ID 7435, SERIAL # (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT; PRODUCT ID 3487A-33, LOT # J0437387V, IMPLANTED: (B)(6) 2005, PRODUCT TYPE LEAD; PRODUCT ID 748951, SERIAL # (B)(4), IMPLANTED: (B)(6) 2005, PRODUCT TYPE EXTENSION; PRODUCT ID 3487A-33, LOT # J0437387V, IMPLANTED: (B)(6) 2005, PRODUCT TYPE LEAD. (B)(4).

    Additional Manufacturer Narrative · 1

    INFORMATION REFERENCES THE MAIN COMPONENT OF THE SYSTEM AND OTHER APPLICABLE COMPONENTS ARE: PRODUCT ID 3550-09 LOT# N0018017 IMPLANTED: (B)(6)2005 PRODUCT TYPE ACCESSORY PRODUCT ID 7435 SERIAL(B)(4) PRODUCT TYPE PROGRAMMER, PATIENT PRODUCT ID 3487A-33 LOT# J0437387V IMPLANTED:(B)(6) 2005 PRODUCT TYPE LEAD PRODUCT ID 748951 SERIAL(B)(4) IMPLANTED: (B)(6)2005 PRODUCT TYPE EXTENSION PRODUCT ID 3487A-33 LOT# J0437387V IMPLANTED: (B)(6)2005 PRODUCT TYPE LEAD IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AFTER THE AUTOMOBILE ACCIDENT THE ¿RIGHT SIDE BROKE¿ AND THE PATIENT DIDN¿T KNOW THAT THE ¿LEADS WERE HANGING.¿ IT WAS REPORTED THAT THEY DID AN MRI AND THE LEADS ¿WEREN¿T TOUCHING MY SPINAL CORD.¿ IT WAS NOTED THAT RIGHT AFTER THE ACCIDENT THEY PUT IN THE PATIENT¿S CERVICAL STIMULATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WAS FEELING STIMULATION IN THE WRONG LOCATION. STIMULATION WAS BEING FELT IN THE PATIENT'S PUBIC BONE AND KNEES, BUT IT SHOULD HAVE BEEN FROM L5 TO S1. THIS OCCURRED AFTER THE PATIENT SUFFERED TRAUMA FROM A CAR ACCIDENT. THE PATIENT EXPERIENCED A CONCUSSION, 2ND DEGREE BURNS, AND NOW THE PATIENT'S DEVICE IS WORKING IN THE WRONG LOCATION. ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CAR ACCIDENT THE PATIENT WAS IN INVOLVED THE CAR FLIPPING THREE TIMES. SHE WENT FOR AN X-RAY AND FOUND OUT THE DEVICE HAD BEEN COMPROMISED. THE PATIENT FELT "SOMETHING WAS WRONG" AND DID NOT HAVE FEELING FROM THE BACK TO THE TOES/SCIATIC AREA. IT WAS NOTED THAT THE PATIENT WAS SCHEDULED FOR SURGERY TO REPLACE THE DEVICE AND POSSIBLY THE WHOLE SYSTEM. IF/WHEN ADDITIONAL INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED FROM THE PATIENT¿S HUSBAND STATING THAT THE PATIENT HAD BEEN IN A CAR ACCIDENT. IT WAS REPORTED THE PATIENT WAS IN AN AUTO ACCIDENT IN 2012 AND THE WIRES IN THEIR BACK WERE BROKEN. IT WAS REPORTED THAT THEY HAD TO ¿REPLACE THE WIRES AND BOXES AND WHATEVER THEY DID, THEY HAD TO DO IT IN TWO OPERATIONS BECAUSE OF SCARE TISSUE¿. THE PATIENT STATED THAT WAS THE ONLY INJURY THEY GOT OTHER THAN LOSING THEIR DENTURES, WHICH THEY NEVER FOUND. IT WAS REPORTED THAT THE EVENT OCCURRED IN (B)(6)2005. NO FURTHER COMPLICATIONS WERE REPORTED/ANTICIPATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNERGY STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MDT PUERTO RICO OPERATIONS CO 7427

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Required Intervention