SURESCAN
Report
- Report Number
- 3004209178-2018-25416
- Event Type
- Malfunction
- Date Received
- November 14, 2018
- Date of Event
- October 12, 2018
- Report Date
- December 12, 2018
- Manufacturer
- MEDTRONIC PUERTO RICO OPERATIONS CO.
- Product Code
- LGW
- UDI-DI
- 00643169109483
- PMA / PMN Number
- P840001
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- SD, US
- Reporter Occupation
- 003
Narratives
IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.
ADDITIONAL INFORMATION WAS RECEIVED FROM THE PATIENT. IT WAS REPORTED THAT THE CIRCUMSTANCES THAT LED TO THE DEVICE TURNING OFF ON ITS OWN AND PAIN/TINGLING WAS JUST THAT THE PATIENT WAS WATCHING TV. THE PATIENT SAID THEY USED THE REMOTE BUTTON TO TRY TO RESOLVE THE ISSUES. THE PATIENT SAID THAT 2 DAYS PRIOR THEY PUT THE CHARGER ON THE INS AND IT SAID TO CALL THE DOCTOR. NO FURTHER COMPLICATIONS WERE REPORTED.
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 PATIENT WHO WAS IMPLANTED WITH AN IMPLANTABLE NEUROSTIMULATOR (INS) FOR SPINAL PAIN. THE PATIENT REPORTED THAT THE INS WAS TURNING OFF BY ITSELF. THE PATIENT REPORTED THAT SHE WAS CHECKING TO MAKE SURE THE DEVICE WAS CHARGED AND WOULD NOTICE THE DEVICE WAS TURNED OFF. THE PATIENT REPORTED THAT THE FIRST TIME WAS ABOUT 4 WEEKS AGO, THEN 2 WEEKS AGO AND AGAIN YESTERDAY. THE PATIENT REPORTED THAT THE DEVICE HAD TURNED OFF BY ITSELF 3 TIMES. THE PATIENT REPORTED THAT THE FIRST TWO TIMES, HE DIDN¿T NOTICE THE DEVICE WAS TURNED OFF, BUT HE STARTED TO ¿FEEL CRAPPY¿ LIKE HIS LOWER BACK GETTING WORSE AND THOUGHT MAYBE IT WAS THE WEATHER OF THE DEVICE WASN¿T WORKING RIGHT. THE PATIENT REPORTED THAT YESTERDAY HE STARTED FEELING SOME SHARP SHOOTING PAIN, TINGLING SPIKE GOING UP AND DOWN HIS BACK. THE PATIENT THOUGHT MAYBE IT WAS FROM AN OLD THORACIC INJURY HE HAD IN 1995 PRIOR TO THE DEVICE. THE PATIENT REPORTED THAT HE HAD NEVER FELT THE SHARP SPIKES BEFORE. THE PATIENT CHECKED THE INS STATUS AND SAW THE DEVICE WAS TURNED OFF AGAIN. THE PATIENT REPORTED THAT HE DIDN¿T KNOW IF THE DEVICE WAS CAUSING THE TINGLING OR IF THE DEVICE TURNING OFF WAS AFFECTING HIM. THE PATIENT REPORTED THAT EVERYTHING TRAVELED FROM THE BUTTOCKS TO HIP. THE PATIENT REPORTED THAT HE HAD BACK ISSUES AND SUED THE DEVICE FOR THE LOWER SPINE TO BE ABLE TO WALK AND THORACIC AREA FROM AN OLD INJURY, PRIOR TO THE DEVICE, WHICH BOTHERED HIM BUT NOT AS MUCH AS IT DID YESTERDAY. THE PATIENT REPORTED THAT HE WOULD CHECK THE INS STATUS WITH THE RECHARGER AND THE LIGHTNING BOLT WOULD BE GONE INDICTING THE DEVICE HAD TURNED OFF. THE PATIENT REPORTED THAT HE WOULD CHECK WITH THE OTHER THING AND THAT WOULD ALSO SHOW THE INS WAS TURNED OFF. THE PATIENT REPORTED THAT THE DEVICE WOULD BE FULLY CHARGED WHEN HE CHECKED THE INS STATUS. THE PATIENT REPORTED THAT THE LAST TWO TIMES THE INS SHUT OFF ¿IT HAPPENED AT THE END OF A CHARGE.¿ THE PATIENT REPORTED THAT HE SAW THE CHARGE WAS COMPLETE AND HE WENT ON WITH HIS DAY. THE PATIENT WENT TO CHARGE THE DEVICE AND THE DEVICE HAD NOT BEEN TURNED ON AND THE INS BATTERY WAS STILL FULLY CHARGED. THE PATIENT REPORTED THAT HE NEVER LET THE INS BATTERY GO TO 0. THE PATIENT REPORTED THAT HE LET THE DEVICE BATTERY GET DOWN TO HALF WAY. NO FURTHER COMPLICATIONS WERE REPORTED.
ADDITIONAL INFORMATION RECEIVED FROM THE HEALTHCARE PROVIDER REPORTED THAT THE CAUSE OF THE DEVICE TURNING OFF ON ITS OWN AND THE TINGLING WAS UNKNOWN. WHEN THEY INTERROGATED THE DEVICE EVERYTHING LOOK NORMAL. THE ISSUE WAS RESOLVED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 910426 | SURESCAN | STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF | LGW | MEDTRONIC PUERTO RICO OPERATIONS CO. | 97714 | 00643169109483 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 80 YR |