BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRIMEADVANCED

    MDR report key: 3630507 · Received February 17, 2014

    Report

    Report Number
    3004209178-2014-03088
    Event Type
    Injury
    Date Received
    February 17, 2014
    Report Date
    January 28, 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
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCT: PRODUCT ID 37743, SERIAL# (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT PRODUCT ID 377775, LOT# V003918, IMPLANTED: 2006-(B)(6), PRODUCT TYPE LEAD, PRODUCT ID 377775, LOT# V004479, IMPLANTED: 2006-(B)(6), PRODUCT TYPE LEAD, PRODUCT ID NEU_SILICONEANCHOR, PRODUCT TYPE ACCESSORY, PRODUCT ID NEU_SILICONEANCHOR, PRODUCT TYPE ACCESSORY. (B)(4).

    Additional Manufacturer Narrative · 1

    ANALYSIS OF THE INS FOUND IT WAS ¿FUNCTIONALLY OKAY¿ AND HAD ¿INSIGNIFICANT ANOMALIES.¿ ANALYSIS OF BOTH LEADS FOUND NO SIGNIFICANT ANOMALY AND THEY HAD BEEN ¿CUT THROUGH¿ AND ¿SEGMENTED.¿ ANALYSIS OF THE TITAN ANCHOR THAT WAS ATTACHED TO THE #0-#7 LEAD FOUND NO SIGNIFICANT ANOMALY AND THAT THE SILICONE HAD BEEN CUT. ANALYSIS OF THE TITAN ANCHOR THAT WAS ATTACHED TO THE #8-#15 LEAD FOUND NO ANOMALY.

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION REPORTED THE PATIENT¿S STIMULATION PROVIDED ¿INSUFFICIENT RELIEF.¿ IT WAS ALSO REPORTED THE PATIENT EXPERIENCED AN ¿INTERNAL BUZZING¿ EVEN WHEN THE STIMULATOR WAS OFF. IT WAS STATED THE INS DID NOT UNDERGO NORMAL BATTERY DEPLETION PRIOR TO EXPLANT. IT WAS NOTED THE PATIENT¿S INS SYSTEM WAS EXPLANTED AS SCHEDULED. IT WAS ALSO NOTED THERE WAS NO PATIENT DEATH OR INJURY AND THE PATIENT ¿RECOVERED WITHOUT SEQUELA¿ FOLLOWING THE EXPLANT PROCEDURE.

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT EXPERIENCED A ¿LOSS OF STIMULATION/THERAPEUTIC EFFECT¿ AND PAIN AT AN UNKNOWN LOCATION. IT WAS FURTHER REPORTED THE PATIENT¿S IMPLANTABLE NEUROSTIMULATOR (INS) ¿HAD NOT WORKED IN A WHILE¿ AND THE PATIENT WANTED THE DEVICE EXPLANTED. IT WAS STATED THAT NO DIAGNOSTIC TESTING OR TROUBLESHOOTING HAD BEEN PERFORMED AND THAT EXPLANT WOULD BE REQUIRED AS A RESULT OF THE EVENT. IT WAS NOTED THE DEVICE WAS TO BE RETURNED TO THE MANUFACTURER UPON EXPLANT. IT WAS REPORTED THE PATIENT WAS ALIVE WITH NO INJURY AT THE TIME OF REPORT. ADDITIONAL INFORMATION REPORTED THE PATIENT WAS SCHEDULED TO HAVE THEIR DEVICE EXPLANTED ON 2014-(B)(6). ADDITIONAL INFORMATION HAS BEEN REQUESTED. A SUPPLEMENTAL REPORT WILL BE FILED IF ADDITIONAL INFORMATION IS RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    100638 PRIMEADVANCED STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37702

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention