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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 Bowel Perforation (2668)
Event Date 03/18/2021
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 shunt valve was removed due to intestinal perforation. A hakim programmable valve was implanted in the patient via a ventricular peritoneal shunt in (b)(6) 1998 with an unknown initial setting due to a right and left cerebral aneurysm. On (b)(6) 2021, the patient was taken to the operating room and the shunt system was removed due to intestinal perforation of the abdominal catheter and the onset of meningitis. The valve was not replaced. Surgical time was extended more than 30 minutes. There was no information available about the meningitis treatment and medications administered for the meningitis. The patient remained in the intensive care unit at the time the complaint was reported. No further information was provided by hospital.
 
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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 Key11653270
MDR Text Key245076355
Report Number3013886523-2021-00169
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,health professional,u
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 06/09/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received04/12/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? No
Device Operator
Device Expiration Date06/30/2003
Device Catalogue NumberXXX-HAKIM PROGRAMMABLE VALVE
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer04/23/2021
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/01/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured06/26/1998
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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