BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TBD

    MDR report key: 3870511 · Received June 12, 2014

    Report

    Report Number
    3004209178-2014-11510
    Event Type
    Injury
    Date Received
    June 12, 2014
    Report Date
    May 21, 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

    ANALYSIS OF THE IMPLANTABLE NEUROSTIMULATOR (INS) (B)(4) FOUND THAT THE BATTERY HAD REDUCED CAPACITY DUE TO OVERDISCHARGE.

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID 377775, LOT# V004859, IMPLANTED: (B)(6) 2006, PRODUCT TYPE LEAD; PRODUCT ID 377775, LOT# V004859, IMPLANTED: (B)(6) 2006, PRODUCT TYPE LEAD; PRODUCT ID 37742, SERIAL# (B)(4), IMPLANTED: (B)(6) 2006, PRODUCT TYPE PROGRAMMER, PATIENT; PRODUCT ID 37754, SERIAL# (B)(4), PRODUCT TYPE RECHARGER. (B)(4).

    Additional Manufacturer Narrative · 1

    CORRECTED INFORMATION: NO EVAL EXPLAIN CODE IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT¿S IMPLANTABLE PULSE GENERATOR (IPG) WAS IN SUSPECTED 1ST OVERDISCHARGE. IT WAS STATED THAT THE PATIENT CALLED THE MANUFACTURER¿S REPRESENTATIVE YESTERDAY WITH ¿CONFUSED QUESTIONS¿ ABOUT HIS RECHARGER. IT WAS REPORTED THAT THE IPG COULD NOT BE READ BY THE PATIENT¿S RECHARGER OR THE CLINICIAN PROGRAMMER (8840). IT WAS REPORTED THAT THE PATIENT DID NOT WANT TO STAY IN THE HEALTHCARE PROFESSIONAL¿S (HCP) OFFICE SO HE WAS SENT HOME WITH INSTRUCTIONS TO PERFORM A PHYSICIAN MODE RECHARGE (PMR) AND WHAT TO LOOK FOR WHEN THE IPG WAS READY TO RECHARGE. IT WAS STATED THAT THE PATIENT ¿SEEMED TO BE GETTING VERY CONFUSED ABOUT HOW TO RUN HIS RECHARGER¿. IT WAS NOTED THAT NO DIAGNOSTIC TESTING OR TROUBLESHOOTING WAS PERFORMED BUT WOULD BE PERFORMED IN THE FUTURE. IT WAS NOTED THAT THE PATIENT¿S DEVICE HAD ¿ALMOST ONE YEAR TO THE DATE LEFT BEFORE EOS (END OF SERVICE)¿. IT WAS STATED THAT THE PATIENT WAS ALIVE WITH NO INJURY. IT WAS STATED THAT THE PATIENT HAD A BURNING SENSATION IN BOTH FEET. IT WAS NOTED THAT THE PATIENT HAD A MEDICAL HISTORY OF PARAPLEGIA. ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE PATIENT WAS SEEN BY A MANUFACTURER¿S REPRESENTATIVE TODAY, NO ADDITIONAL INFORMATION AVAILABLE. ADDITIONAL INFORMATION WOULD BE ADDED AS IT WAS RECEIVED. ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE PATIENT WAS NOT ABLE TO RECHARGE FOR MORE THAN 10-15 MINUTES WITHOUT RECEIVING A POR (POWER ON RESET) ON HIS RECHARGER. IT WAS STATED THAT THE SYSTEM WOULD NOT ALLOW THE MANUFACTURER¿S REPRESENTATIVE TO CLEAR IT WITH THE 8840. IT WAS STATED THAT THE PATIENT WAS INTERESTED IN REPLACING HIS BATTERY WITH A PRIME (NON-RECHARGEABLE) AND HAD AN APPOINTMENT WITH A HCP ON (B)(6). NO ADDITIONAL INFORMATION WAS AVAILABLE. ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE POR COULD NOT BE CLEARED AND THAT THE PATIENT HAD A HARD TIME FOLLOWING SOME DIRECTIONS NOW. IT WAS STATED THAT SINCE THE IPG WAS AT 8 YEARS, AND HE WAS HAVING AN ¿APPARENT MENTAL CHALLENGE¿ WITH HIS RECHARGER, THE PATIENT WAS SENT TO THE HCP FOR AN APPOINTMENT TO REPLACE HIS IPG WITH A PRIMARY CELL IPG.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE PATIENT'S BATTERY WAS REPLACED. IT WAS NOTED THAT A DIFFERENT MANUFACTURER'S REPRESENTATIVE WAS PRESENT FOR THE REPLACEMENT.

    Description of Event or Problem · 1

    (B)(4).

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE RECHARGEABLE IMPLANTABLE NEUROSTIMULATOR (INS) WAS REPLACED WITH A PRIMARY CELL INS ON (B)(6) 2014. IT WAS NOTED THAT THE PATIENT HAD NOT BEEN ABLE TO RECHARGE HIS DEVICE, AND IT WAS REPORTED THAT OVER THE COURSE OF 2 DAYS THEY COULD NOT GET THE INS CHARGED ENOUGH TO CLEAR THE POR. IT WAS STATED THAT AFTER DISCUSSIONS WITH THE PATIENT AND HEALTHCARE PROFESSIONAL (HCP), THE HCP SENT THE PATIENT TO THE SURGEON FOR REPLACEMENT WITH A 37702. IT WAS STATED THAT THE MANUFACTURER'S REPRESENTATIVE SAW THE PATIENT LAST WEEK AND HE WAS HAPPY WITH HIS STIMULATION PAIN RELIEF AND GLAD NOT TO HAVE TO RECHARGE. IT WAS STATED THAT THE PATIENT WAS USING 1.8/20 AMPS 24/7. IT WAS NOTED THAT THE PATIENT WAS NOT A CLINICAL STUDY PARTICIPANT. IT WAS STATED THAT THE DEVICE WAS RETURNED TO THE MANUFACTURER ON 2014-JUL-18, DISASSEMBLY OF THE DEVICE WAS ALLOWED FOR ANALYSIS, BUT AN ANALYSIS REPORT WAS NOT REQUESTED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE MANUFACTURER'S REPRESENTATIVE SENT THE EXPLANTED IPG AND PAPERWORK BACK YESTERDAY. IT WAS STATED THAT THE PATIENT "REALLY NEEDED A PRIME-CELL." IT WAS REPORTED THAT THE PATIENT WAS GETTING VERY GOOD PAIN RELIEF. IT WAS STATED THAT THE MANUFACTURER'S REPRESENTATIVE DID NOT REMEMBER THE PATIENT TALKING ABOUT A BURNING SENSATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    348361 TBD STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37711AA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention