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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: INTEGRA LIFESCIENCES SWITZERLAND SAR IN LINE HAKIM UNITIZED PROGRAM CHPV

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INTEGRA LIFESCIENCES SWITZERLAND SAR IN LINE HAKIM UNITIZED PROGRAM CHPV Back to Search Results
Catalog Number NS9009
Device Problem Electrical /Electronic Property Problem (1198)
Patient Problems Neurological Deficit/Dysfunction (1982); Injury (2348)
Event Date 04/15/2020
Event Type  Injury  
Manufacturer Narrative
Attempts are being made to obtain additional information. Upon completion of the investigation, a follow-up report will be submitted.
 
Event Description
A physician reported difficulty to change the setting of the hakim valve. The valve was implanted via l-p shunt on (b)(6) 2015. An initial setting was unknown. The valve was used with the silascon® lumbar catheter (manufactured by kaneka, product code: 702-jj). The patient symptoms got worse (gait disorder and cerebral ventricular enlargement) and it was difficult to change the setting when attempted. Also, lumbar catheter dislodgement was confirmed. Therefore, on (b)(6) 2020 was explanted and replaced with a new valve.
 
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Brand NameIN LINE HAKIM UNITIZED PROGRAM
Type of DeviceCHPV
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
325 paramount drive
raynham, MA 02767
6099362319
MDR Report Key10280296
MDR Text Key202699893
Report Number1226348-2020-00221
Device Sequence Number1
Product Code JXG
Combination Product (y/n)N
PMA/PMN Number
NI
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign
Reporter Occupation
Type of Report Initial,Followup
Report Date 04/17/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received07/15/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? No
Device Operator
Device Expiration Date09/30/2019
Device Catalogue NumberNS9009
Device Lot NumberKP104543
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer05/18/2020
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/12/2020
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured10/07/2014
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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