FDA Adverse Event
Malfunction
Summary report: N
PRIMEADVANCED
MDR report key: 3062049
·
Received April 16, 2013
Report
- Report Number
- 9614453-2013-00989
- Event Type
- Malfunction
- Date Received
- April 16, 2013
- Date of Event
- April 3, 2013
- Report Date
- April 3, 2013
- Manufacturer
- IPG MFG SWITZERLAND
- Product Code
- LGW
- PMA / PMN Number
- P840001
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
PRODUCT ID: 3999-45 LOT# SERIAL# UNKNOWN, PRODUCT TYPE LEAD. (B)(4).
Additional Manufacturer Narrative · 1
(B)(4)
Additional Manufacturer Narrative · 1
(B)(4)
Description of Event or Problem · 1
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
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 162680 | PRIMEADVANCED | STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF | LGW | IPG MFG SWITZERLAND | 37702 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 00062 YR |