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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: INTEGRA LIFESCIENCES SWITZERLAND SAR CERTAS INLIN VLV SPHN/UNIT CAT CERTAS PLUS W/ SG

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INTEGRA LIFESCIENCES SWITZERLAND SAR CERTAS INLIN VLV SPHN/UNIT CAT CERTAS PLUS W/ SG Back to Search Results
Catalog Number 828806
Device Problem Output Problem (3005)
Patient Problem Failure of Implant (1924)
Event Type  Injury  
Manufacturer Narrative
The certas valve was not returned for evaluation (remains implanted) and no lot number information has been provided; therefore, an evaluation of the device could not be performed, and manufacturing records could not be reviewed. The cause(s) of the difficulty reported by the customer could not be determined. If additional relevant information becomes available in the future, this complaint will be reopened, and the respective evaluation performed. Trends will be monitored for this and similar issues. At present, we consider this complaint to be closed. The possible root cause for the event reported by the customer: ¿unable to change the setting; inversion was confirmed. The valve was reversed and fixed subcutaneously in the suture hole" could be due to "valve is not sufficiently fixated when placed in the lumbar space (suture tabs not sufficiently utilized)".
 
Event Description
2 of 2 reports. Other mfg report number: 3013886523-2021-00422. (same valve different failures). A physician reported a certas valve was implanted in a male patient (70-80 years-old) due to inph (idiopathic normal pressure hydrocephalus) via l-p shunt on unknown date with unknown setting. The valve was used with silascon lumbar catheter (manufactured by kaneka, product code: 702-jj). In august- early september 2021, under-drainage occurred. Shunt contrast and image confirmed that the abdominal catheter had deviated, and water had accumulated in the abdomen. It was performed re-placement of abdominal catheter. It is unknown if the patient presented signs and symptoms due to the dysfunction. When the physician checked the certas valve settings the setting, it should have been 7 , but it was 5, the physician tried to change the pressure using etk and it was unsuccessful. When the valve was confirmed inverted by x-ray. The valve was reversed and fixed subcutaneously in the suture hole. The patient's condition was good.
 
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Brand NameCERTAS INLIN VLV SPHN/UNIT CAT
Type of DeviceCERTAS PLUS W/ SG
Manufacturer (Section D)
INTEGRA LIFESCIENCES SWITZERLAND SAR
rue girardet 29
rue girardet 29
le locle
SZ
Manufacturer (Section G)
INTEGRA LIFESCIENCES SWITZERLAND SAR
rue girardet 29
ch-2400
le locle
SZ
Manufacturer Contact
vivian nelson
1100 campus drive
princeton, NJ 
6099362319
MDR Report Key12582772
MDR Text Key274922255
Report Number3013886523-2021-00423
Device Sequence Number1
Product Code JXG
Combination Product (y/n)N
PMA/PMN Number
K143111
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional,u
Reporter Occupation
Type of Report Initial
Report Date 10/06/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received10/06/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? No
Device Operator
Device Catalogue Number828806
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/16/2021
Was Device Evaluated by Manufacturer? No Answer Provided
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

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