• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: INTEGRA LIFESCIENCES SWITZERLAND SAR MICRO CHPV W RICKHAM UNITIZED

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

INTEGRA LIFESCIENCES SWITZERLAND SAR MICRO CHPV W RICKHAM UNITIZED Back to Search Results
Catalog Number 823113
Device Problem Protective Measures Problem (3015)
Patient Problems Fatigue (1849); Hematoma (1884); Confusion/ Disorientation (2553)
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
It was reported by the nurse practitioner that a rickham reservoir programmable valve was placed on (b)(6) 2017, however the patient developed significant subdural hematoma requiring surgical evacuation on (b)(6) 2017. At that time, the concern was even at 200mm h20 with an ant- syphon device; there was still too much drainage. At the time of the subdural evacuation a 2nd valve was placed in tandem and setting for a total pressure setting 320mm h20. This was accomplished 200mm h20 of superior valve #1 and 120mm h20 of inferior valve #2. The patient did well at 320mm h20. The hospital made one adjustment on september 19, 2017 of the inferior valve #2 to 110mm h20. On (b)(6) 2019 the patient began to develop symptoms of confusion, severe fatigue, difficulty concentrating and focusing, sleeping through the entire last 3 weekends. On (b)(6) 2019, his ventricles were appreciably larger, and his shunt valves were checked by skull film which confirmed superior valve #1 at 140mm (not 200mm as previously programmed) and 100mm h20 on inferior #2. The patient was admitted and made several adjustments and his ventricles changed sizes respectively. He was discharged with superior valve at 150mm superior #1 and 100mm inferior #2 with stable ventricles. On (b)(6) 2019, the patient underwent mri and reprogrammed per physician recommendation with vpv confirmation 100mm superior #1 and 120mm inferior #2. When skull film was completed, it was confirmed 30mm superior #1 at and 120mm inferior #2. He was admitted and taken to or for revision of superior valve #1 with a fixed pressure high pressure valve, and inferior valve #2 was confirmed at 100mm.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameMICRO CHPV W RICKHAM UNITIZED
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 Key10276715
MDR Text Key207343820
Report Number1226348-2019-00631
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 company representative,health
Reporter Occupation
Type of Report Initial,Followup
Report Date 12/17/2019
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 Date10/31/2021
Device Catalogue Number823113
Device Lot Number108687
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/20/2020
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received03/31/2020
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured11/16/2016
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

-
-