FDA Adverse Event
Malfunction
Summary report: N
PISCES-QUAD
MDR report key: 3034942
·
Received April 4, 2013
Report
- Report Number
- 6000153-2013-00055
- Event Type
- Malfunction
- Date Received
- April 4, 2013
- Report Date
- March 13, 2013
- Manufacturer
- NEURO - VILLALBA
- Product Code
- LGW
- PMA / PMN Number
- P840001
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CO, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID NEU_SPINALNEEDLE. PRODUCT TYPE: ACCESSORY. (B)(4).
Additional Manufacturer Narrative · 1
ANALYSIS OF THE LEAD (LOT # V121083) REVEALED NO ANOMALY. ANALYSIS OF THE SPINAL NEEDLE REVEALED IT WAS PACKAGED INCORRECTLY.
Additional Manufacturer Narrative · 1
IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THE HEALTHCARE PROVIDER INSPECTED THE KIT AND NOTICED PLASTIC WAS STUCK TO THE NEEDLE. IT WAS ALSO REPORTED IT LOOKED LIKE THE PLASTIC PIECE THAT CAME PACKAGED WITH THE NEEDLE HAD MELTED TO THE NEEDLE. IT WAS POSSIBLE TO SEE THE INDENTION ON THE PLASTIC PIECE. THE DEVICE WAS NOT USED IN THE PATIENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 138631 | PISCES-QUAD | STIMULATOR, SPINAL-CORD, IMPLANTED (PAIN RELIEF) | LGW | NEURO - VILLALBA | 3487A-56 | V121083 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |