PRIMEADVANCED
Report
- Report Number
- 3004209178-2013-08222
- Event Type
- Malfunction
- Date Received
- May 29, 2013
- Report Date
- May 6, 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
- MN, US
- Reporter Occupation
- OTHER
Narratives
(B)(4).
(B)(4).
CONCOMITANT PRODUCTS: PRODUCT ID 37746, SERIAL # (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT; PRODUCT ID 3778-60, SERIAL # (B)(4), IMPLANTED: (B)(6) 2013, PRODUCT TYPE LEAD. (B)(4).
FOLLOW UP INFORMATION OBTAINED REPORTED PATIENT WAS REPROGRAMMED AGAIN. IT WAS NOTED THAT IMPEDANCES WERE OKAY AND COMPARISON OF X-RAYS TAKEN AT THE TRIAL, AT IMPLANT, AND POST-OPERATIVELY ALL LOOKED THE SAME. THE PATIENT WAS UNABLE TO GET STIMULATION IN THE LOW BACK AREA AS THEY DID DURING THE TRIAL (THERE WAS A VERY ¿SLIGHT STIMULATION¿ IN THE LOW BACK DURING THE TRIAL) AND ONLY GOT STIMULATION TO THE LEGS. IT WAS REPORTED THAT THE PATIENT HAD ONE TRIAL LEAD AND ONE ¿IMPLANT¿ LEAD (THIS PHYSICIAN USUALLY IMPLANTS ONE LEAD). THE PATIENT WAS GETTING STIMULATION THERAPY ALTHOUGH NOT TO THE LOW BACK AREA WHICH IS WHERE THE MAJORITY OF THEIR PAIN WAS. THE PHYSICIAN RECOMMENDED THAT THE PATIENT KEEP THE INS SYSTEM THERAPY FOR A WHILE AND WAS TO SEE THEM ON (B)(6) 2013 TO DISCUSS EXPLANTATION IF THERE WAS NO IMPROVEMENT. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW UP REPORT WILL BE SENT.
ADDITIONAL INFORMATION RECEIVED REPORTED THE ELECTIVE REPLACEMENT INDICATOR (ERI) WAS TRIPPED DUE TO EXTREMELY HIGH USAGE.THE PATIENT WAS REPROGRAMMED, CYCLING AND ¿BAT¿ WERE ADDED. THE PATIENT HAD STIMULATION IN MOST DESIRED AREAS, SIMILAR TO TRIAL, BUT WAS RECEIVING NO PAIN RELIEF. IT WAS NOTED THE PATIENT WAS ¿VERY CONFUSED MOST OF THE TIME AND IT WAS DIFFICULT TO GET A CLEAR ANSWER.¿ ADDITIONAL INFORMATION RECEIVED 6 DAYS LATER REPORTED X-RAYS SHOWED NO LEAD MIGRATION AS COMPARED TO IMPLANT X-RAY. THE PATIENT WAS TO KEEP USING STIMULATION FOR A FEW WEEKS AND THEN SCHEDULE A FOLLOW-UP APPOINTMENT WITH HER PHYSICIAN.
IT WAS REPORTED THAT THE PATIENT MET WITH THE MANUFACTURER¿S REPRESENTATIVE ON (B)(6) 2013 AT WHICH TIME IT WAS OBSERVED THAT THEIR IMPLANTABLE NEUROSTIMULATOR (INS) HAD AN ELECTIVE REPLACEMENT INDICATOR (ERI) MESSAGE 6 WEEKS POST IMPLANT. THE BATTERY VOLTAGE MEASURED WAS 2.6 VOLTS. IT WAS NOTED THAT THE PATIENT WAS PREVIOUSLY SEEN ON (B)(6) 2013 AT WHICH THE PATIENT WAS USING THE INS AT 8.0 VOLTS. WHEN THE PATIENT WAS SEEN ON MAY 6, 2013 BY THE MANUFACTURER¿S REPRESENTATIVE, THE PATIENT¿S INS WAS AT 10.1 VOLTS. THE PATIENT WAS SUPPOSED TO BE SEEN THE WEEK BEFORE BUT THEY KEPT CANCELING. IT WAS NOTED THAT THE CYCLING FEATURE OF THE INS WAS TO BE ADDED ¿EARLIER.¿ DURING THE TRIAL PHASE, THE PATIENT WAS AT A SETTING OF 5 TO 5.5 VOLTS. THE INS BATTERY LONGEVITY CALCULATION WAS ESTIMATED TO BE 7 MONTHS BASE ON PATIENT SETTINGS OF 1 PROGRAM, 8.0 VOLTS, 50 HZ, PULSE WIDTH OF 360, 4 CATHODES, 1 ANODE, USED 24 HOURS WITH NO CYCLING. THE LONGEVITY CALCULATION WAS 5 MONTHS WHEN THE INS SETTING WAS AT 10.1 VOLTS (SAME SETTINGS AS ABOVE). IT WAS REPORTED THAT THE DEVICE THERAPY HAD NOT HELPED THE PATIENT¿S PAIN AT ALL AND WAS NOTED AS A ¿10 OUT OF 10.¿ THE TRIAL PHASE OF TESTIN G DID HELP THE PATIENT. THE PATIENT COULD NOT FEEL THE STIMULATION AT 10.1 VOLTS WHEN SEEN ON (B)(6) 2013. THE PATIENT WAS REPROGRAMMED TO 2 ANODES, 2 CATHODES, 8.4 VOLTS, AND 20 HZ AND COULD FEEL THE STIMULATION ALTHOUGH THEY DID NOT ¿LIKE THIS.¿ THE PATIENT WAS THEN PROGRAMMED WITH CYCLING TO 0.1 SEC ON AND 0.1 SEC OFF. IT WAS NOTED THAT THE PATIENT COULD NOT SEE OR HEAR AND COULD HARDLY HANDLE TURNING THE INS ON OR OFF (OR UP AND DOWN). THE PATIENT HAD ACCESS TO CHANGE THE AMPLITUDE ONLY. FOLLOW UP INFORMATION RECEIVED REPORTED THAT THE PATIENT WAS SCHEDULED TO MEET WITH THE MANUFACTURER¿S REPRESENTATIVE ON (B)(6) 2013 BUT THEY WERE NOT FEELING WELL AND WAS RESCHEDULED TO MEET ON (B)(6) 2013. ADDITIONAL INFORMATION RECEIVED ON (B)(6) 2013 AGAIN REPORTED THE ERI MESSAGE AND THE BATTERY DEPLETION WAS NOTED AS PREMATURE. IT WAS EXPECTED THAT EH END-OF-SERVICE (EOS) STATUS WAS TO OCCUR IN THE NEXT FEW WEEKS. IT WAS ALSO REPORTED THAT THE PATIENT HAD BEEN PROGRAMMED WITH ¿A LOT OF ACTIVE ELECTRODES.¿ THE PATIENT WAS USING THE INS AT 10.1 VOLTS BUT COULD NOT FEEL THE STIMULATION. IT WAS CONFIRMED THAT THE PATIENT WAS REPROGRAMMED TO LOWER AMPLITUDES AND DID GET UNILATERAL COVERAGE FOR THEIR PAIN. THE PATIENT DID NOT LIKE THE CYCLING THAT THEY WERE PROGRAMMED WITH. IT WAS CONFIRMED THAT THE PATIENT WAS GETTING NO RELIEF FOR THE PAIN BUT COULD FEEL THE STIMULATION. IT WAS NOTED THAT THE PATIENT HAD DIFFICULTY USING THE PROGRAMMER UNIT. FURTHER INFORMATION RECEIVED ON (B)(6) 2013 REPORTED THAT THE PATIENT WAS SEEN TODAY AND WAS REPROGRAMMED TO 2 CATHODES AND 2 ANODES CONFIGURATION AT 6.5 VOLTS AT A RATE OF 90 WITH NO CYCLING. IMPEDANCE MEASUREMENTS WERE REPORTED AS ¿FINE.¿ IT WAS REPORTED THAT THE BATTERY HAD RECOVERED TO A READING OF 3.015 VOLTS SINCE (B)(6) AT WHICH TIME THE PROGRAMMING WAS CHANGED. IT WAS NOTED THAT THE PATIENT WAS ¿NOT A GOOD HISTORIAN¿ AS TO WHAT THEIR COVERAGE WAS BUT IT APPEARED THAT THEY GETTING STIMULATION IN THE LEGS AND A LITTLE IN THE BUTTOCKS BUT NOT TO THE LOW BACK AREA. THE PATIENT STATED THAT THEY HAVE HAD NO THERAPY RELIEF SINCE IMPLANTATION OF THE INS SYSTEM DESPITE THE STIMULATION PATTERN BEING THE COVERAGE FOR THEIR LEFT LEG. IT WAS REPORTED THAT THEY HAD NO COVERAGE FOR THE BUTTOCK AREA. THE PATIENT WAS TO BE SEEN IN 2 WEEKS. THE PATIENT¿S PHYSICIAN HAD ORDERED AN X-RAY TO VERIFY THE PLACEMENT OF THE LEAD. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW-UP REPORT WILL BE SENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 237191 | PRIMEADVANCED | STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF | LGW | MEDTRONIC MED REL MEDTRONIC PUERTO RICO | 37702 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |