FDA Adverse Event
Malfunction
Summary report: N
1 X 8 EXTENSION KIT
MDR report key: 3100640
·
Received May 8, 2013
Report
- Report Number
- 6000153-2013-00091
- Event Type
- Malfunction
- Date Received
- May 8, 2013
- Date of Event
- April 23, 2013
- Report Date
- April 23, 2013
- Manufacturer
- NEURO - VILLALBA
- Product Code
- LGW
- PMA / PMN Number
- P840001
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FR
- Reporter Occupation
- HEALTH PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
(B)(6). (B)(4).
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THE EXTENSION HAD IMPEDANCE MEASUREMENTS HIGHER THAN 10 ,000 OHMS. IT WAS STATED THE EXTENSION WAS RECONNECTED THREE TIMES AND WAS "NO GOOD WITH HIGH IMPEDANCES." IT WAS NOTED THE PATIENT'S EXTENSION WAS CHANGED DURING THE IMPLANT SURGERY. THE PATIENT'S OUTCOME WAS REPORTED AS ALIVE WITH NO INJURY OR ADVERSE EVENT AND IT WAS STATED THERE WERE NO PATIENT SYMPTOMS OR INJURIES RELATED TO THIS EVENT. ADDITIONAL INFORMATION HAS BEEN REQUESTED. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, A SUPPLEMENTAL REPORT WILL BE FILED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 201810 | 1 X 8 EXTENSION KIT | STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF | LGW | NEURO - VILLALBA | 37081-60 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 00050 YR |