FDA Adverse Event
Malfunction
Summary report: N
ACTIVA
MDR report key: 4210266
·
Received October 29, 2014
Report
- Report Number
- 6000153-2014-00185
- Event Type
- Malfunction
- Date Received
- October 29, 2014
- Date of Event
- October 10, 2014
- Report Date
- October 10, 2014
- Manufacturer
- NEURO - VILLALBA
- Product Code
- MHY
- PMA / PMN Number
- P960009
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MN, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
ANALYSIS OF THE LEAD FOUND THE DISTAL END OF THE LEAD WAS BENT (NEW OUT OF THE BOX). ALL LEAD ELECTRODES WERE EVENT AND THE DISTAL TIP OF THE LEAD WAS OFF CENTER. THERE WERE MULTIPLE BENDS IN THE LEAD.
Additional Manufacturer Narrative · 1
PRODUCT ID: NEU_STYLET_ACC, SERIAL# UNKNOWN, PRODUCT TYPE: ACCESSORY. (B)(4). ANALYSIS RESULTS WERE NOT AVAILABLE AS OF THE DATE OF THIS REPORT. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN ANALYSIS IS COMPLETE.
Additional Manufacturer Narrative · 1
IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.
Description of Event or Problem · 1
IT WAS REPORTED THE LEAD WAS ¿BENT/WARPED¿ AT THE DISTAL TIP AND THE LEAD WAS NOT IMPLANTED. THERE WERE NO PATIENT SYMPTOMS OR COMPLICATIONS ASSOCIATED WITH THIS EVENT AND THE PATIENT STATUS AT THE TIME OF THIS REPORT WAS ALIVE WITH NO INJURY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 693474 | ACTIVA | STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR | MHY | NEURO - VILLALBA | 3387S-40 | VA0N0XR |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 00066 YR |