FDA Adverse Event
Malfunction
Summary report: N
INTELLIS
MDR report key: 7895672
·
Received September 20, 2018
Report
- Report Number
- 3004209178-2018-21176
- Event Type
- Malfunction
- Date Received
- September 20, 2018
- Date of Event
- September 18, 2018
- Report Date
- September 20, 2018
- Manufacturer
- MEDTRONIC PUERTO RICO OPERATIONS CO.
- Product Code
- LGW
- UDI-DI
- 00643169781702
- PMA / PMN Number
- P840001
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- WA, US
- Reporter Occupation
- OTHER
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 MANUFACTURER REPRESENTATIVE REGARDING A PATIENT WITH AN IMPLANTABLE NEUROSTIMULATOR (INS). IT WAS REPORTED THAT THE IMPEDANCES WERE CHECKED AND THE FOLLOWING IMPEDANCES WERE RECORDED ON THE FOLLOWING CONTACTS: 1 - 40000 (DO NOT USE) 2 - 20370 (AVOID) 3 - 40000 (DO NOT USE) THE PATIENT WAS STILL ABLE TO RECEIVE ADEQUATE THERAPY. NO SYMPTOMS OR COMPLICATIONS WERE REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 734564 | INTELLIS | STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF | LGW | MEDTRONIC PUERTO RICO OPERATIONS CO. | 97715 | 00643169781702 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 78 YR |