MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2020-03-13 for PROGAV 2.0 SYS W/SA20 A.CONTROL RESERV. FX434T manufactured by Christoph Miethke Gmbh & Co. Kg.
[183374017]
The product was not returned. Manufacturing and quality control data - without a serial number it is not possible for us to retrace the complained product. Nevertheless, we can ensure that a progav 2. 0 shunt system has a normal pressure range of 0-2c cm h2o. The shunt system was inspected. All parameters are inspected and signed during the manufacturing process. Complaint history - see the complaint history in regards to the article number over the last 3 years: 2017 - 5 total complaints - 2 with similar malfunction. 2018 - 5 total complaints - 0 with similar malfunction. 2019 - 5 total complaints - 1 with similar malfunction. 2020 - 2 total complaints - 2 with similar malfunction. No corrective actions were needed. Result - an investigation was not possible because no product was available. Based on the complaint description it could be possible that any deposits of protein have caused the valve's non-adjustability. As described in scientific literature, the problem encountered is one of the known, inevitable risks of hydrocephalus therapy by shunt implants. However, we cannot fully clarify what influenced the valve condition, as this would require an examination of the valve. No further actions are required.
Patient Sequence No: 1, Text Type: N, H10
[183374018]
It was reported that there was an issue with the shunt system. The patient was initially implanted on an unspecified date. Sometime after the implantation, the symptoms of the patient were "not so well" and ventricular enlargement was confirmed. So, the surgeon tried to adjust the pressure to 0cm but it did not improve. After this, the surgeon took out the progav and implanted another company's product instead. The surgeon noted that perhaps the size of the product had not been appropriate to the patient when he chose the product. Also, the surgeon did not try to flash since he had no idea that the product was able to be flashed. There was no blockage found within the catheter that was taken out at the same time as the valve. A revision was performed due to the malfunction. Additional information was not provided. Associated medwatches: 3004721439-2020-00064, 3004721439-2020-00065.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3004721439-2020-00064 |
| MDR Report Key | 9830126 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2020-03-13 |
| Date of Report | 2020-03-13 |
| Date of Event | 2018-02-25 |
| Date Mfgr Received | 2020-02-28 |
| Date Added to Maude | 2020-03-13 |
| 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 | PROGAV 2.0 SYS W/SA20 A.CONTROL RESERV. |
| Generic Name | HYDROCEPHALUS MANAGEMENT |
| Product Code | JXG |
| Date Received | 2020-03-13 |
| Model Number | FX434T |
| Catalog Number | FX434T |
| Lot Number | 20034694 |
| 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 | 2020-03-13 |