MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-03-17 for PROGAV 2.0 SYS W/SA10 A.CONTROL RESERV. FX432T manufactured by Christoph Miethke Gmbh & Co. Kg.
[183891913]
Possible lot number 20039562 (to be confirmed). Additional information / investigation results will be provided in a supplemental report, if applicable.
Patient Sequence No: 1, Text Type: N, H10
[183892494]
It was reported that there was an issue with the shunt system. The patient was initially implanted with a progav valve with control reservoir. Sometime later, there was difficulty in re-programming noted. The clinical application specialist nor the surgeon could adjust the setting. There was a revision surgery to replace the defective valve. Additional information has been requested (including clarification on event date and awareness dates).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2916714-2020-00069 |
| MDR Report Key | 9842244 |
| Date Received | 2020-03-17 |
| Date of Report | 2020-03-17 |
| Date of Event | 2020-02-04 |
| Date Facility Aware | 2020-02-04 |
| Date Added to Maude | 2020-03-17 |
| Event Key | 0 |
| Report Source Code | Distributor report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | PROGAV 2.0 SYS W/SA10 A.CONTROL RESERV. |
| Generic Name | HYDROCEPHALUS MANAGEMENT |
| Product Code | JXG |
| Date Received | 2020-03-17 |
| Model Number | FX432T |
| Catalog Number | FX432T |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CHRISTOPH MIETHKE GMBH & CO. KG |
| Manufacturer Address | 2 ULANENWEG POTSDAM, 14469 GM 14469 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2020-03-17 |