BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRIMEADVANCED

    MDR report key: 3150505 · Received June 6, 2013

    Report

    Report Number
    3004209178-2013-08733
    Event Type
    Injury
    Date Received
    June 6, 2013
    Report Date
    May 17, 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
    MO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID 3998, LOT# V009630, IMPLANTED: 2006-(B)(6), PRODUCT TYPE LEAD PRODUCT ID 3708240, SERIAL# (B)(4), IMPLANTED: 2006-(B)(6), EXPLANTED: 2013-(B)(6), PRODUCT TYPE EXTENSION PRODUCT ID 37743, SERIAL# (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT PRODUCT ID 3550-29, LOT# N185094, IMPLANTED: 2010-(B)(6), PRODUCT TYPE ACCESSORY. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    FINAL DEVICE ANALYSIS OF THE EXTENSION REVEALED THE FOLLOWING: ALL CONDUCTORS WERE BROKEN 8.5 CM FROM THE PROXIMAL END OF THE EXTENSION.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION REPORTED THE PATIENT¿S EXTENSION WAS EXPLANTED DUE TO OPEN CONNECTIONS AND A FRACTURE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT EXPERIENCED NO STIMULATION SENSATION FOLLOWING A FALL. IT WAS STATED THAT APPROXIMATELY ONE MONTH PRIOR TO THE REPORT, THE PATIENT SLIPPED AND STARTED TO FALL FORWARD BUT FELL BACKWARD ON HER BOTTOM AND IMPLANT SITE. IT WAS REPORTED THAT THE STIMULATION STARTED TO WORK ONLY INTERMITTENTLY AND POSITIONALLY, AND THE NEXT DAY AFTER THE FALL THE PATIENT STOPPED FEELING ANY STIMULATION EVEN AFTER INCREASING THE AMPLITUDE. IT WAS STATED THAT THE PATIENT DID GO TO THE HOSPITAL THAT DAY AND WAS DIAGNOSED WITH A STRAINED BACK, KNEE, TORN LIGAMENTS/STRAIN IN HAND AND CONCUSSION. IT WAS ALSO REPORTED THAT THE PATIENT TOLD THE REPORTER THE BATTERY IN HER STIMULATOR "WENT OUT." IT WAS STATED THAT THE LAST TIME THE PATIENT'S BATTERY WENT OUT "SOMEONE CAME OVER AND RECHARGED OR REPLACED HER BATTERY," HOWEVER, THE PATIENT HAD A NON-RECHARGEABLE INS (IMPLANTABLE NEUROSTIMULATOR) AND IT WOULD INVOLVE SURGERY TO REPLACE THE INS. ALMOST TWO WEEKS LATER IT WAS REPORTED THAT THERE WERE HIGH IMPEDANCES, > 3600 ON ALL CONTACTS. IT WAS STATED THAT IT WAS PLANNED TO TROUBLESHOOT INTRA-OPERATIVELY TO FIND DISCONNECT WITH A POSSIBLE LEAD/EXTENSION/INS REVISION/REPLACEMENT. PATIENT STATUS AT THE TIME OF THIS REPORT WAS NOTED AS ALIVE WITH NO INJURY/NO ADVERSE EVENT. PATIENT SYMPTOMS/COMPLICATIONS WERE LESS THAN 50% THERAPY RELIEF AT THE EXTENSION AND LEAD LOCATIONS. THREE DAYS LATER IT WAS REPORTED THAT LEAD REVISION WAS SCHEDULED FOR (B)(6) 2013. INS POCKET WAS OPENED AND MLTC (MULTI-LEAD TRIALING CABLE) SHOWED STILL ALL OPEN CONNECTIONS (>10,000 OHMS). AFTER OPENING MID-LINE SPINAL INCISION WHERE THE LEAD CONNECTED TO THE EXTENSION, DISCONNECTING THE EXTENSION FROM THE LEAD, AND CONNECTING THE LEAD DIRECTLY INTO MLTC, ALL CONNECTIONS WERE WITHIN NORMAL RANGE, SO IT WAS DECIDED TO REPLACE THE EXTENSION. WHEN REMOVING EXTENSION, A FRACTURE NEAR ITS PROXIMAL END COULD BE SEEN. AFTER THE REPLACEMENT, ALL CONNECTIONS WERE WITHIN NORMAL RANGE. IT WAS STATED THAT THE PATIENT WAS DOING WELL POST-OP WITH GOOD STIMULATION. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT. WHEN RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    UPON FURTHER REVIEW, IT WAS REPORTED THAT THE DEVICE WOULD NOT COME ON.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    251613 PRIMEADVANCED STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37702

    Patients

    Seq Age Sex Outcome Treatment
    1 00051 YR Required Intervention