RESTORE SENSOR
Report
- Report Number
- 3004209178-2019-10701
- Event Type
- Malfunction
- Date Received
- June 3, 2019
- Date of Event
- January 1, 2018
- Report Date
- August 1, 2019
- Manufacturer
- MEDTRONIC MED REL MEDTRONIC PUERTO RICO
- Product Code
- LGW
- UDI-DI
- 00613994610430
- PMA / PMN Number
- P840001
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NV, US
- Reporter Occupation
- 003
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.
THE CONSUMER REPORTED VIA THE MANUFACTURER REPRESENTATIVE THAT THEY HAD INTERMITTENT SHOCKING SENSATIONS THAT AFFECTED THEIR LEGS. NO EXTERNAL OR PATIENT FACTORS WERE KNOWN TO HAVE CONTRIBUTED TO THE ISSUE. THE PATIENT WAS SEEN AT THEIR PHYSICIAN¿S OFFICE ON (B)(6) 2019 AND ALL IMPEDANCES WERE WITHIN NORMAL LIMITS AND THE PATIENT STATED THE PARESTHESIA WAS SATISFACTORY. THE PATIENT WAS GOING TO MEET WITH THEIR PHYSICIAN AND THE ISSUE WAS NOT RESOLVED AT THE TIME OF THE REPORT.
ADDITIONAL INFORMATION RECEIVED FORM THE MANUFACTURER REPRESENTATIVE REPORTED THAT THE PATIENT WAS SEEN BY THEIR HEALTHCARE PROVIDER ON (B)(6). THE CAUSE OF THE SHOCKING WAS NOT DETERMINED AND THE PATIENT WAS THINKING ABOUT A BATTERY CHANGE BUT NO SURGERY HAS BEEN PLANNED. THE PATIENT HAD NOT FELT THE SHOCKING SINCE THE ORIGINAL INCIDENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 456371 | RESTORE SENSOR | STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF | LGW | MEDTRONIC MED REL MEDTRONIC PUERTO RICO | 37714 | 00613994610430 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 60 YR |