PROG VALVE CLYNDRICAL W PRECHA
Report
- Report Number
- 3013886523-2023-00047
- Event Type
- Injury
- Date Received
- February 21, 2023
- Date of Event
- February 2, 2023
- Report Date
- May 3, 2023
- Manufacturer
- INTEGRA LIFESCIENCES MANSFIELD
- Product Code
- JXG
- UDI-DI
- 10381780519133
- PMA / PMN Number
- K122118
- Report Source
- Manufacturer report
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
THE HAKIM VALVE WAS RETURNED FOR EVALUATION: DHR - LOT 5822407, CONFORMED TO THE SPECIFICATIONS WHEN RELEASED TO STOCK. FAILURE ANALYSIS - THE VALVE WAS VISUALLY INSPECTED; NO DEFECT WAS NOTED. THE VALVE PASSED THE TESTS FOR PROGRAMMING, OCCLUSION, LEAK, REFLUX AND PRESSURE. ROOT CAUSE - NO ROOT CAUSE COULD BE DETERMINED AS THE TECHNICIAN COULD NOT CONFIRM ANY PROBLEM WITH THE VALVE AT THE TIME OF INVESTIGATION. THE POSSIBLE ROOT CAUSE FOR THE ISSUE REPORTED BY THE CUSTOMER, COULD BE DUE TO BIOLOGICAL DEBRIS AND PROTEIN BUILD UP INTERFERING WITH THE VALVE, AT THE TIME OF INVESTIGATION NO PROGRAMING ISSUES WERE NOTED.
AN INVESTIGATION HAS BEEN INITIATED BASED ON THE REPORTED INFORMATION. UPON COMPLETION OF THE INVESTIGATION, A FOLLOW-UP REPORT WILL BE SUBMITTED.
ADDITIONAL INFORMATION RECEIVED: INITIAL IMPLANTATION : (B)(6) 2023. EXPLANTATION DATE: (B)(6) 2023 . NO PATIENT SYMPTOMS. PATIENT IS DOING WELL AFTER NEW VALVE IMPLANTATION. PATIENT IS AN ADULT.
N/A
A FACILITY REPORTED A HAKIM VALVE (ID 823110) WAS NOT POSSIBLE TO REPROGRAM AN IT WAS EXPLANTED AND REPLACED.
N/A.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1408206 | PROG VALVE CLYNDRICAL W PRECHA | CHPV | JXG | INTEGRA LIFESCIENCES MANSFIELD | 823110 | 5822407 | 10381780519133 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown |