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 PROGAV 2.0 SYSTEM WITH CONTROL RESERVOIR FX431T manufactured by Christoph Miethke Gmbh & Co. Kg.
[188548928]
Manufacturing and quality control data - we have only received the product data, article number (b)(4) and serial number (b)(4). The product itself is not available for an investigation. Nevertheless, our traceability can prove that there were no deviations. The valve was manufactured by a qualified employee in december 2017. Deviations during assembly did not occur. The progav has a normal pressure range of 0 to 20 cmh2o. All parameters (opening pressure, reflux, adjustability and brake function) are inspected and signed during the manufacturing process. Investigation: description incoming product condition: no products received for investigation. Optical inspection : not applicable, because no products were available for investigation. Testing : not applicable, because no products were available for investigation. Result : an investigation was not possible because no product was sent for it. Please note that it is important to position the adjustment tool centrally over the valve. Please be aware that the steps for changing the pressure setting should not be more than 8 cmh2o per step. The rotor turns correctly. Please note that despite correct use of the setting tool, it may be difficult to adjust the valve as the skin swells in the first few days postoperatively. In the treatment of hydrocephalus with shunts, the following complications may arise: infections, blockages caused by protein and/or blood in the cerebrospinal fluid, over/under drainage or in very rare cases noise development. Violent shocks from the outside (accident, fall) may put the integrity of the shunt system at risk. Why the valve to adjusted itself does not explain us. This would require an examination of the product. Further actions: based on the current information, no further actions are required from our point of view.
Patient Sequence No: 1, Text Type: N, H10
[188548929]
It was reported that there was an issue with the shunt system, via a complaint form and information from medwatch (b)(4). The patient was initially implanted with a progav valve on (b)(6) 2018, which had been set to a specific setting. Postoperatively, the setting changed and became lower. It was reset but changed a second time on the same day. This led to over-drainage of the ventricles and intracranial hypotension; the patient experienced cerebellar hemorrhage and "decline" in his exam. Emergency craniotomy was performed 2 days later for decompression. Clot evaluation and valve replacement occurred soon after. It was noted that the valve had reset on its own again prior to that revision. The patient remained intubated and was transferred to the intensive care unit (icu) after the surgery. Additional information was not provided, however, it has been requested.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3004721439-2020-00063 |
| MDR Report Key | 9825988 |
| Report Source | COMPANY REPRESENTATIVE,USER F |
| Date Received | 2020-03-12 |
| Date of Report | 2020-03-12 |
| Date of Event | 2018-03-19 |
| Date Mfgr Received | 2018-03-23 |
| Device Manufacturer Date | 2017-12-06 |
| 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 | PROGAV 2.0 SYSTEM WITH CONTROL RESERVOIR |
| Generic Name | HYDROCEPHALUS MANAGEMENT |
| Product Code | JXG |
| Date Received | 2020-03-12 |
| Model Number | FX431T |
| Catalog Number | FX431T |
| Lot Number | 20035872 |
| 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 |