MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,user f report with the FDA on 2020-03-12 for PROSA VALVE FV701T manufactured by Christoph Miethke Gmbh & Co. Kg.
[188544317]
The device was not available for investigation and the surgeon did not give permission for testing. Further information will be reported, if received.
Patient Sequence No: 1, Text Type: N, H10
[188544318]
It was reported that there was an issue with the shunt system. The patient was initially implanted with a prosa valve on an unspecified date. Postoperatively, the setting was moved from 32 to 20 sometime around (b)(6) 2017. After that date, the prosa could not be adjusted by the surgeon nor by the aesculap clinical application specialist on (b)(6) 2018. The patient experienced "illness and grave symptoms" as a result of improper cerebrospinal fluid (csf) drainage. The valve was explanted and revised due to the complications. Additional information was not provided, however, it has been requested.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3004721439-2020-00062 |
| MDR Report Key | 9825681 |
| Report Source | COMPANY REPRESENTATIVE,USER F |
| Date Received | 2020-03-12 |
| Date of Report | 2020-03-12 |
| Date of Event | 2018-04-22 |
| Date Mfgr Received | 2018-05-04 |
| Device Manufacturer Date | 2016-05-03 |
| Date Added to Maude | 2020-03-12 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| 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 |
| Manufacturer Contact | MR. JOERG KNEBEL |
| Manufacturer Street | 2 ULANENWEG |
| Manufacturer City | POTSDAM D, 14469 |
| Manufacturer Country | GM |
| Manufacturer Postal | 14469 |
| Manufacturer G1 | CHRISTOPH MIETHKE GMBH & CO. KG |
| Manufacturer Street | 2 ULANENWEG |
| Manufacturer City | POTSDAM, 14469 |
| Manufacturer Country | GM |
| Manufacturer Postal Code | 14469 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | PROSA VALVE |
| Generic Name | HYDROCEPHALUS MANAGEMENT |
| Product Code | JXG |
| Date Received | 2020-03-12 |
| Model Number | FV701T |
| Catalog Number | FV701T |
| Lot Number | 20030179 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| 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 | 2020-03-12 |