FDA Adverse Event
Malfunction
Summary report: N
RESTORE SENSOR
MDR report key: 9458067
·
Received December 12, 2019
Report
- Report Number
- 3004209178-2019-23670
- Event Type
- Malfunction
- Date Received
- December 12, 2019
- Date of Event
- January 1, 2018
- Report Date
- December 12, 2019
- Manufacturer
- MEDTRONIC PUERTO RICO OPERATIONS CO.
- Product Code
- LGW
- UDI-DI
- 00613994610430
- PMA / PMN Number
- P840001
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AL, US
- Reporter Occupation
- 003
Narratives
Additional Manufacturer Narrative · 1
IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.
Description of Event or Problem · 1
INFORMATION WAS RECEIVED FROM A PATIENT WHO WAS IMPLANTED WITH AN IMPLANTABLE NEUROSTIMULATOR (INS) FOR NON-MALIGNANT PAIN. THE PATIENT REPORTED THAT LAST YEAR 8 ¿DIOS¿ DIED AND FIZZLED OUT. THE PATIENT REPORTED THAT THIS JUST TOOK HER DOWN TO THE FLOOR BECAUSE IT WAS VERY PAINFUL. THE PATIENT REPORTED THAT ABOUT 2 AND A HALF MONTHS AGO, THE SAME THING HAPPENED WHERE 8 ¿DIOS¿ DIED AND SHE ¿HAD THE SAME TYPE OF FEELING.¿ NO FURTHER COMPLICATIONS WERE REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1254889 | RESTORE SENSOR | STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF | LGW | MEDTRONIC PUERTO RICO OPERATIONS CO. | 37714 | 00613994610430 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 66 YR |