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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: INTEGRA LIFESCIENCES SWITZERLAND SAR HAKIM PROGRAMMABLE VALVE CHPV

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INTEGRA LIFESCIENCES SWITZERLAND SAR HAKIM PROGRAMMABLE VALVE CHPV Back to Search Results
Catalog Number XXX-HAKIM PROGRAMMABLE VALVE
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Nausea (1970)
Event Date 12/02/2021
Event Type  Injury  
Manufacturer Narrative
An investigation has been initiated based on the reported information. Upon completion of the investigation, a follow-up report will be submitted.
 
Event Description
A physician reported a (b)(6) valve was implanted in a (b)(6) male via vp shunt on (b)(6) 2018 with setting (b)(4). The pressure changed and it was possible to change it; however, the valve was removed and replaced on (b)(6) 2021 due to nausea symptom. According to the physician, the patient seemed to hit his head while sleeping, and it was possible that the parts inside the valve were damaged. Patient is recovered.
 
Manufacturer Narrative
An investigation has been initiated based on the reported information. Upon completion of the investigation, a follow-up report will be submitted.
 
Event Description
A physician reported a hakim valve was implanted in a (b)(6) male via vp shunt on (b)(6) 2018 with setting 120mmh2o. The pressure changed and it was possible to change it; however, the valve was removed and replaced on (b)(6) 2021 due to nausea symptom. According to the physician, the patient seemed to hit his head while sleeping, and it was possible that the parts inside the valve were damaged. Patient is recovered.
 
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Brand NameHAKIM PROGRAMMABLE VALVE
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
1100 campus drive
princeton, NJ 
6099362319
MDR Report Key13022511
MDR Text Key285414607
Report Number3013886523-2021-00562
Device Sequence Number1
Product Code JXG
Combination Product (y/n)N
PMA/PMN Number
K053107
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional,User Facility
Reporter Occupation
Type of Report Initial,Followup
Report Date 02/15/2022
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/16/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? No
Device Operator
Device Expiration Date04/30/2022
Device Catalogue NumberXXX-HAKIM PROGRAMMABLE VALVE
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/24/2022
Is the Reporter a Health Professional? Yes
Date Manufacturer Received01/28/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured05/19/2017
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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