FDA Adverse Event
Injury
Summary report: N
TBD
MDR report key: 5343637
·
Received January 5, 2016
Report
- Report Number
- 6000153-2016-00012
- Event Type
- Injury
- Date Received
- January 5, 2016
- Report Date
- December 10, 2015
- Manufacturer
- NEURO - VILLALBA
- Product Code
- LGW
- PMA / PMN Number
- P840001
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IA, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
CONCOMITANT PRODUCTS: PRODUCT ID: 377845, LOT# V010268, IMPLANTED: (B)(6) 2006, PRODUCT TYPE: LEAD. (B)(4).
Description of Event or Problem · 1
THE CONSUMER REPORTED THAT THE PATIENT HAD A LEAD REVISION IN (B)(6) 2015. ADDITIONAL INFORMATION RECEIVED FROM THE HEALTHCARE PROVIDER (HCP) IN RESPONSE TO FOLLOW-UP REPORTED THAT 3 ELECTRODES HAD SHOWED IMPEDANCE READINGS OUT OF VARIANCE. THE PATIENT HAD NOT BEEN PERCEIVING STIMULATION OR AT TIMES WOULD RECEIVE UNCOMFORTABLE BURSTS OF STIMULATION. IMPEDANCE READING ANALYSIS AND REPROGRAMMING WERE ATTEMPTED ON (B)(6) 2015 PRIOR TO THE REVISION. RELEVANT MEDICAL HISTORY INCLUDED SPINAL PAIN. NO FURTHER FOLLOW-UP WAS REQUIRED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 4891 | TBD | STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF | LGW | NEURO - VILLALBA | 377845 | V010268 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |