BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PRIMEADVANCED

    MDR report key: 3832752 · Received May 27, 2014

    Report

    Report Number
    3004209178-2014-09616
    Event Type
    Malfunction
    Date Received
    May 27, 2014
    Report Date
    May 22, 2014
    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
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    PRODUCT ID: 97740, SERIAL# (B)(4), PRODUCT TYPE: PROGRAMMER. PATIENT PRODUCT ID: 3777-60, SERIAL# (B)(4), IMPLANTED: (B)(6) 2013, PRODUCT TYPE: LEAD. PRODUCT ID: 3777-60, SERIAL# (B)(4), IMPLANTED: (B)(6) 2013, PRODUCT TYPE: LEAD. (B)(4).

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THE PATIENT COMPLAINED TO THE PHYSICIAN OF AN INCREASE IN PAIN. THE PATIENT WAS REPORTEDLY ON A BUS MONDAY, AND THE BUS HIT A BUMP AND THE PATIENT HEARD A "POP" IN HER BACK. THE PHYSICIAN WANTED THE PATIENT'S STIM ADJUSTED BEFORE ANYTHING ELSE WAS ORDERED. IT WAS NOTED THE MANUFACTURER REPRESENTATIVE (REP) WAS ABLE TO GIVE THE PATIENT BETTER COVERAGE IN HER LOW BACK, BUT THE PATIENT STILL WANTED A "SHOT AND AN X-RAY. THE PHYSICIAN SENT THE PATIENT OUT FOR AN X-RAY. BETTER BACK COVERAGE WAS ACHIEVED WITH CONTACTS 432 PROGRAMMED ++- AT A PULSE WIDTH OF 270 AND A RATE OF 7.3. **OF NOTE: AFTER FURTHER REVIEW, HIGH IMPEDANCE ISSUE PREVIOUSLY REPORTED PERTAINS TO SEPARATE EVENT. REFERENCE MFR REPORT #30042091 78-2014-02778.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THE PATIENT COMPLAINED TO THE PHYSICIAN OF AN INCREASE IN PAIN. THE PATIENT WAS REPORTEDLY ON A BUS MONDAY, AND THE BUS HIT A BUMP AND THE PATIENT HEARD A ¿POP¿ IN HER BACK. THE PHYSICIAN WANTED THE PATIENT¿S STIM ADJUSTED BEFORE ANYTHING ELSE WAS ORDERED. IT WAS NOTED THE MANUFACTURER REPRESENTATIVE (REP) WAS ABLE TO GIVE THE PATIENT BETTER COVERAGE IN HER LOW BACK, BUT THE PATIENT STILL WANTED A ¿SHOT¿ AND AN X-RAY. THE PHYSICIAN SENT THE PATIENT OUT FOR AN X-RAY. THE PATIENT¿S SYSTEM IMPEDANCE READ CONTACTS 8 AND 11 WERE OVER 10,000 OHMS. BETTER BACK COVERAGE WAS ACHIEVED WITH CONTACTS 432 PROGRAMMED ++- AT A PULSE WIDTH OF 270 AND A RATE OF 7.3. ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT IT WAS NOT AVAILABLE AT THE TIME OF INITIAL REPORT. A SUPPLEMENTAL REPORT WILL BE SENT IF ANY ADDITIONAL INFORMATION IS RECEIVED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED IT WAS UNKNOWN IF THERE WAS 50% OR GREATER SYMPTOMS REDUCTION. IT WAS REPORTED X-RAYS WERE TAKEN ON (B)(6) 2014 AND IT WAS FOUND THERE WAS NO LEAD MOVEMENT OR COMPRESSION OR FRACTURE. IT WAS NOTED AT FOLLOW-UP ON (B)(6) 2014, THERE WERE NO NEW PAIN COMPLAINTS. IT WAS REPORTED THE CAUSE OF THE EVENT WAS UNKNOWN BUT DETERMINED TO BE NOT RELATED TO THEIR DEVICE. IT WAS REPORTED THE PATIENT RECOVERED WITHOUT PERMANENT IMPAIRMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    310573 PRIMEADVANCED STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37702

    Patients

    Seq Age Sex Outcome Treatment
    1 00070 YR