It was reported that the valve does not program.The reporter indicated that a post operative progav sys w/sa 20 a.Control reservoir was implanted in the patient on (b)(6) 2019, however, the valve does not program and the patient required a re-operation.Additional details of the event are not available.
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Investigation optical inspection not applicable, because no products were available for examination.Permeability test not applicable, because no products were available for examination.Adjustment test not applicable, because no products were available for examination.Braking force and brake function test not applicable, because no products were available for examination.Result an investigation was not possible because no product was send for investigation.We point out that it is important to position the adjustment tool centrally over the valve.Please keep in mind, that despite of a correct use of the adjustment tool it may can be difficult to adjust the valve due to a postoperative swelling of the skin within the first few days.In addition, as described in our literature, any deposits of protein or blood that may be present can as well affect the functioning of the valve.What actually has led to the difficulties in adjusting, does not explain to us, since this would require an investigation of the product.Further actions based on the current information, no further actions are required from our point of view.
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