FDA Adverse Event
Malfunction
Summary report: N
HAKIM PROGRAMMABLE VALVE
MDR report key: 4532282
·
Received February 20, 2015
Report
- Report Number
- 1226348-2015-10106
- Event Type
- Malfunction
- Date Received
- February 20, 2015
- Date of Event
- November 11, 2014
- Manufacturer
- CODMAN & SHURTLEFF, INC.
- Product Code
- JXG
- PMA / PMN Number
- PK974739
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- SZ
- Reporter Occupation
- MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE
Narratives
Additional Manufacturer Narrative · 1
(B)(4). IT WAS NOT POSSIBLE TO INVESTIGATE THE COMPLAINT AS NO SAMPLE WAS RETURNED FOR EVALUATION. IF THE SAMPLE IS RETURNED IN THE FUTURE, THIS COMPLAINT WILL BE RE-OPENED AND EVALUATED. REVIEW OF THE HISTORY DEVICE RECORDS CONFIRMED THE VALVE PRODUCT CODE 82-3115, WITH LOT CPNBZB, CONFORMED TO THE SPECIFICATIONS WHEN RELEASED TO STOCK ON THE 10TH JANUARY 2014. BASED ON THE RESULTS OF THIS INVESTIGATION NO FURTHER ACTION IS REQUIRED. TRENDS WILL BE MONITORED FOR THIS AND SIMILAR COMPLAINTS. AT THE PRESENT TIME THIS COMPLAINT IS CLOSED. DEVICE NOT AVAILABLE.
Description of Event or Problem · 1
LECKAGE OF VALUE BEFORE IMPLANTATION. (B)(6) 2015 ADDITIONAL INFORMATION LOT NUMBER IS CPNBZB PRODUCT CODE 82-3115 AND THE DEVICE WILL NOT BE RETURNED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 122190 | HAKIM PROGRAMMABLE VALVE | NERVOUS SYSTEM & COMPONENTS | JXG | CODMAN & SHURTLEFF, INC. | CPNBZB |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |