INTELLIS
Report
- Report Number
- 3004209178-2018-06188
- Event Type
- Malfunction
- Date Received
- April 2, 2018
- Report Date
- April 17, 2018
- Manufacturer
- MEDTRONIC PUERTO RICO OPERATIONS CO.
- Product Code
- LGW
- UDI-DI
- 00643169781702
- PMA / PMN Number
- P840001
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OK, US
- Reporter Occupation
- OTHER
Narratives
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.
INFORMATION WAS RECEIVED FROM A CONSUMER VIA A MANUFACTURER'S REPRESENTATIVE (REP) REGARDING AN IMPLANTABLE NEUROSTIMULATOR (INS). IT WAS REPORTED THAT THE PATIENT HAD A CHANGE IN HOW LONG THE BATTERY WILL STAY CHARGED BETWEEN CHARGING SESSIONS. THE PATIENT WAS CONTACTED AND REPORTED THAT THEY CHARGE THEIR INS DAILY EACH MORNING. THE DEVICE USED TO SHOW 40% EACH MORNING, BUT THE LAST COUPLE OF WEEKS IT HAS BEEN GOING DOWN TO "RED AND SHUTTING OFF." THE PATIENT STATED THAT THEY THEN WAKE UP IN PAIN. THE PATIENT STATED THAT THEY HAVE NOT ADJUSTED THE INTENSITY OR CHANGED ANY OF THE SETTINGS. THE PATIENT IS GETTING GREAT RELIEF AND IS WEENING OFF THEIR PAIN MEDICATIONS. THE PATIENT WILL CHARGE TWICE A DAY IF NECESSARY. THE REP STATED THAT THEY ARE TENTATIVELY MEETING WITH THE PATIENT NEXT WEEK. NO FURTHER COMPLICATIONS WERE REPORTED OR ANTICIPATED.
ADDITIONAL INFORMATION RECEIVED FROM THE REP REPORTED THAT NO ACTIONS HAD BEEN TAKEN TO RESOLVE THE ISSUE, AND THAT THE ISSUE HAD NOT BEEN RESOLVED. NO FURTHER COMPLICATIONS WERE REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 231955 | INTELLIS | STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF | LGW | MEDTRONIC PUERTO RICO OPERATIONS CO. | 97715 | 00643169781702 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |