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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: INTEGRA LIFESCIENCES SWITZERLAND SAR MEDOS PROG INFANT VALVESYSTEM CHPV

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INTEGRA LIFESCIENCES SWITZERLAND SAR MEDOS PROG INFANT VALVESYSTEM CHPV Back to Search Results
Catalog Number 823101
Device Problems Electrical /Electronic Property Problem (1198); Device Dislodged or Dislocated (2923)
Patient Problem Injury (2348)
Event Date 01/16/2020
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
The hakim valve was implanted via vp-shunt due to secondary normal pressure hydrocephalus (snph) about 10 years ago. An initial setting was unknown. During the last 10 years, the patient developed an aneurysm many times and mri has been performed frequently. Since the last year, the valve unable to change the setting, therefore the valve was replaced with a new valve on (b)(6) 2020. At explant, the physician noticed that the cam was dislodged from the base plate. After the replacement, the patient is doing well. Primary disease: sah (subarachnoid hemorrhage).
 
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Brand NameMEDOS PROG INFANT VALVESYSTEM
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 Key10293588
MDR Text Key202705231
Report Number1226348-2020-00445
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 company representative,foreig
Reporter Occupation
Type of Report Initial,Followup
Report Date 01/16/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received07/19/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? No
Device Operator
Device Catalogue Number823101
Device Lot Number1270297
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer02/14/2020
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/14/2020
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured02/17/2005
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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