RESTORE ULTRA
Report
- Report Number
- 3004209178-2016-17825
- Event Type
- Injury
- Date Received
- August 29, 2016
- Date of Event
- January 1, 2014
- Report Date
- November 8, 2018
- 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
- NC, US
- Reporter Occupation
- 003
Narratives
THE MAIN COMPONENT OF THE SYSTEM AND OTHER APPLICABLE COMPONENTS ARE: PRODUCT ID 3998, LOT # V855145, IMPLANTED: (B)(6) 2011, PRODUCT TYPE LEAD; PRODUCT ID 3998, LOT # V855145, IMPLANTED: (B)(6) 2011, PRODUCT TYPE LEAD; PRODUCT ID 37743, SERIAL # (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT; PRODUCT ID 37752, SERIAL # (B)(4), PRODUCT TYPE RECHARGER; PRODUCT ID 3550-29, LOT # N293627, IMPLANTED: (B)(6) 2011, PRODUCT TYPE ACCESSORY; PRODUCT ID 3708240, SERIAL # (B)(4), IMPLANTED: (B)(6) 2011, PRODUCT TYPE EXTENSION.
A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.
PRODUCT ID: 3998, LOT# V855145, IMPLANTED: (B)(6) 2011, PRODUCT TYPE: LEAD; PRODUCT ID: 3998, LOT# V855145, IMPLANTED: (B)(6) 2011, PRODUCT TYPE: LEAD; PRODUCT ID: 37743, SERIAL# (B)(4), PRODUCT TYPE: PROGRAMMER, PATIENT; PRODUCT ID: 37752, SERIAL# (B)(4), PRODUCT TYPE: RECHARGER; PRODUCT ID: 3550-29, LOT# N293627, IMPLANTED: (B)(6) 2011, PRODUCT TYPE: ACCESSORY; PRODUCT ID: 3708240, SERIAL# (B)(4), IMPLANTED: (B)(6) 2011, PRODUCT TYPE: EXTENSION. ANALYSIS OF THE IMPLANTABLE NEUROSTIMULATOR (SERIAL NUMBER (B)(4)) FOUND THAT THE DEVICE WAS AT END OF SERVICE DUE TO THREE OVERDISCHARGES. DUE TO IMDRF HARMONIZATION, ANY PREVIOUSLY SUBMITTED DEVICE, METHOD, RESULT, AND CONCLUSION CODES NO LONGER APPLY TO THIS EVENT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.
IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.
A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.
IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.
IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.
DUE TO IMDRF HARMONIZATION, ANY PREVIOUSLY SUBMITTED DEVICE, METHOD, RESULT, AND CONCLUSION CODES NO LONGER APPLY TO THIS EVENT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.
PRODUCT ID (B)(4) LOT# V855145 SERIAL# IMPLANTED: (B)(4) 2011 EXPLANTED: PRODUCT TYPE LEAD PRODUCT ID (B)(4) LOT# V855145 SERIAL# IMPLANTED: (B)(4) 2011 EXPLANTED: PRODUCT TYPE LEAD PRODUCT ID (B)(4) LOT# SERIAL# (B)(4) IMPLANTED: EXPLANTED: PRODUCT TYPE PROGRAMMER, PATIENT PRODUCT ID 37752 LOT# SERIAL# (B)(4) IMPLANTED: EXPLANTED: PRODUCT TYPE RECHARGER PRODUCT ID (B)(4) LOT# N293627 SERIAL# IMPLANTED: (B)(4) 2011 EXPLANTED: PRODUCT TYPE ACCESSORY PRODUCT ID (B)(4)LOT# SERIAL# (B)(4) IMPLANTED: (B)(4) 2011 EXPLANTED: PRODUCT TYPE EXTENSION EVALUATION METHOD CODE (B)(4) NO LONGER APPLIES IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.
IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.
(B)(4). ANALYSIS RESULTS WERE NOT AVAILABLE AT THE TIME OF THIS REPORT. A FOLLOW-UP REPORT WILL BE SENT WHEN ANALYSIS IS COMPLETED. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.
THE CONSUMER REPORTED THAT THE PATIENT WAS UNABLE TO CHARGE THE IMPLANTABLE NEUROSTIMULATOR (INS). THE PATIENT FIRST STATED THE RECHARGER WAS NOT CHARGING, AND THE PATIENT WAS NOT GETTING COUPLING BARS. THE REPORTED ISSUES BEGAN ON (B)(6) 2015, AND THE PATIENT LAST CHARGED THE INS A MONTH AND A HALF AGO. BEST PRACTICES FOR RECHARGING WERE REVIEWED; THE PATIENT WAS INSTRUCTED TO PLACE THE RECHARGE ANTENNA OVER THE INS. THE RECHARGER ICON WAS ABOUT 3/4 CHARGED, AND REPOSITIONING THE ANTENNA DID NOT RESOLVE THE ISSUE. DURING TROUBLESHOOTING, THE PATIENT CONFIRMED THE RECHARGER HAD A GREEN LIGHT AND THE CORD WAS PLUGGED IN PROPERLY. THE PATIENT WAS INSTRUCTED TO TRY TO CHARGE THE IMPLANT, AND THE PATIENT REPORTED GETTING THE ¿POOR COMMUNICATION¿ PICTURE ON THE RECHARGER SCREEN. IN ADDITION, THE PATIENT STATED THE RECHARGER WAS SHOWING IT WAS FULLY CHARGED. THERE WAS NO COMMUNICATION ON THE PATIENT PROGRAMMER; THE PATIENT WAS GETTING THE ¿POOR COMMUNICATION¿ ON THE PATIENT PROGRAMMER. IT WAS REVIEWED THAT THE INS MAY BE IN AN OVERDISCHARGED STATE, AND THE PATIENT NEEDED TO CONTACT THE HEALTHCARE PROFESSIONAL'S OFFICE. ADDITIONAL INFORMATION RECEIVED FROM THE CONSUMER ON (B)(6) 2016 REPORTED THAT THE PATIENT NEEDED TO TURN THE IMPLANT BACK ON AND THE HEALTHCARE PROFESSIONAL DID NOT WORK WITH THE MANUFACTURER. THE PATIENT WAS UNABLE TO CHARGE THE IMPLANT SINCE MAYBE LAST YEAR, BUT HE WAS NOT SURE. THE PATIENT STATED ¿HE DID NOT KNOW IT WAS BROKEN.¿ A PHYSICIAN LIST WAS REQUESTED. THERE WERE NO REPORTED PATIENT SYMPTOMS THE PATIENT¿S INDICATIONS FOR USE INCLUDED NON-MALIGNANT PAIN.
ADDITIONAL INFORMATION RECEIVED FROM THE CONSUMER REPORTED THEY HADN¿T CONTACTED A PHYSICIAN REGARDING THEIR ISSUES. THE CONSUMER FURTHER CLARIFIED THAT WHEN THEY SAID THE DEVICE WAS BROKEN¿ THEY MEANT THEY COULDN¿T GET IT TO CHARGE, AND THEY MUST HAVE GONE TOO LONG WITHOUT CHARGING. IT WAS REVIEWED WITH THE CONSUMER THAT ONCE THEY FOUND A PHYSICIAN THEY COULD REQUEST A MANUFACTURER¿S REPRESENTATIVE (REP) MEET WITH THEM.
ADDITIONAL INFORMATION RECEIVED FROM THE CONSUMER VIA THE MANUFACTURER'S REPRESENTATIVE (REP) REPORTED THEY WERE IN A MOTORCYCLE ACCIDENT TWO YEARS AGO, AND HADN'T USED THE IMPLANTABLE NEUROSTIMULATOR (INS) SINCE, AND AS A RESULT IT BECAME OVERDISCHARGED. AN ATTEMPT WAS MADE TO INTERROGATE THE DEVICE WITH THE CLINICIAN PROGRAMMER, BUT THERE WAS NO RESPONSE. A TRICKLE CHARGE WAS PERFORMED IN THE OFFICE WHICH WAS UNSUCCESSFUL SO THE CONSUMER WAS SENT HOME WITH A TRICKLE CHARGE. CURRENTLY THE ISSUE WASN'T RESOLVED, BUT THE REP. WAS PLANNING ON CONTACTING THE CONSUMER NEXT WEEK FOR FURTHER FOLLOW-UP.
ADDITIONAL INFORMATION RECEIVED FROM THE CONSUMER REPORTED THAT HIS BATTERY WAS SHUT DOWN AND HE WANTED TO GET IN CONTACT WITH A MANUFACTURER REPRESENTATIVE. FURTHER INFORMATION RECEIVED FROM THE CONSUMER REPORTED THAT THE BATTERY JUST SHUT OFF AND HE NEEDED THE REPRESENTATIVE TO REBOOT IT. THE PATIENT STATED THAT THE IMPLANT HAD BEEN DEAD FOR A YEAR OR TWO AND COULD NOT RECALL THE EXACT TIME. THE PATIENT NOTED HE HAD MET WITH A REPRESENTATIVE WHO TOLD HIM THE DEVICE WAS TOO LOW AND COULDN¿T RESET IT IN (B)(6) OF AN UNKNOWN YEAR. THE PATIENT MENTIONED SEEING A DOCTOR CODE, HOWEVER, HE DIDN'T RECALL WHAT THE CODE WAS JUST A DOCTOR PICTURE. THE PATIENT HAD A DOCTOR¿S APPOINTMENT THE DAY OF THE REPORT.
ADDITIONAL INFORMATION RECEIVED FROM THE CONSUMER REPORTED THAT HE HAD LOST HIS PROGRAMMER AND FINALLY GOT A NEW ONE. THE PATIENT STATED THAT EVERY TIME HE WOULD TRY TO CHARGE THE IMPLANT A SCREEN WOULD POP UP WITH A PICTURE OF A DOCTOR AND HE WAS TOLD TO MEET WITH A MANUFACTURER REPRESENTATIVE ABOUT IT. THE PATIENT NOTED THE LAST TIME HE SUCCESSFULLY CHARGED THE IMPLANT WAS ABOUT (B)(6) 2017. THE PATIENT MENTIONED BEING TOLD TO MEET WITH A REPRESENTATIVE TO HAVE THEM RESTART THE IMPLANT.
ADDITIONAL INFORMATION WAS RECEIVED FROM THE PATIENT. THE PATIENT REPORTED THAT THEY HAD SET UP AN APPOINTMENT WITH A PAIN MANAGEMENT PLACE AND NEEDED A MANUFACTURER REPRESENTATIVE (REP) TO COME RESTART HIS UNIT. THE PATIENT WAS DIRECTED BACK TO THEIR HEALTHCARE PROFESSIONAL TO COORDINATE AN APPOINTMENT WITH A REP. NO FURTHER COMPLICATIONS WERE REPORTED/ANTICIPATED.
ADDITIONAL INFORMATION WAS RECEIVED FROM THE PATIENT VIA A MANUFACTURER REPRESENTATIVE (REP) REPORTING THAT THE PATIENT¿S BATTERY WAS DEPLETED. FACTORS THAT MAY HAVE LED/CONTRIBUTED TO THE REPORTED ISSUE WAS THE PATIENT WAS IN A MOTOR CYCLE ACCIDENT IN 2014 AND HAD EXTENSIVE HOSPITALIZATION AND THEY HAD NOT USED THEIR STIMULATOR SINCE. IT WAS REPORTED THAT DURING TROUBLESHOOTING THERE WAS NO RESPONSE FROM THE CLINICIAN PROGRAMMER. IT WAS REPORTED THAT THE INS WAS GOING TO BE REPLACED WITH A PRIME BATTERY. THE ISSUE WAS RESOLVED AT THE TIME OF THE REPORT. THE INS WAS REPLACED ON (B)(4) 2018. THE EVENT OCCURRED IN 2014. NO FURTHER COMPLICATIONS WERE REPORTED/ANTICIPATED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 561743 | RESTORE ULTRA | STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF | LGW | MEDTRONIC MED REL MEDTRONIC PUERTO RICO | 37712 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 47 YR | Required Intervention |