FDA Adverse Event
Malfunction
Summary report: N
PROGAV SYSTEM PED. WITH PRECHAMBER
MDR report key: 3812624
·
Received April 17, 2014
Report
- Report Number
- 2916714-2014-00274
- Event Type
- Malfunction
- Date Received
- April 17, 2014
- Date of Event
- March 18, 2014
- Report Date
- April 17, 2010
- Manufacturer
- CHRISTOPHE MIETHEKE GMBH & CO KG.
- Product Code
- JXG
- PMA / PMN Number
- K062009
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MA, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
MANUFACTURING SITE EVALUATION: EVALUATION ON-GOING.
Description of Event or Problem · 1
VP SHUNT PLACEMENT / NEUROSURGEON IS REPORTING TWO COMPLAINTS WITH FV438T; PROGAV VALVE COMPONENT ONLY. TWO PATIENTS EXPERIENCE POST OPERATIVE OVERDRAINAGE; BOTH PATIENTS HAD SUBDURAL HEMATOMAS THAT REQUIRED FURTHER SURGERY. BOTH VALVES IMPLANTED IN (B)(6) 2014. PATIENTS PRESENTED IN (B)(6) WITH SEVERE SUBDURAL HEMATOMAS WHICH REQUIRED ADDITIONAL SURGERY TO HAVE THE HEMATOMAS EVACUATED. VALVE EXPLANTED 3/8.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 236281 | PROGAV SYSTEM PED. WITH PRECHAMBER | HYDROCEPHALUS VALVES | JXG | CHRISTOPHE MIETHEKE GMBH & CO KG. | FV438T |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |