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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC NEUROSURGERY PERITONEAL CATHETER, STANDARD, OPEN END, BARIUM IMPREGNATED, 120 CM SHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS

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MEDTRONIC NEUROSURGERY PERITONEAL CATHETER, STANDARD, OPEN END, BARIUM IMPREGNATED, 120 CM SHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS Back to Search Results
Model Number 23047
Device Problem Migration (4003)
Patient Problem Bowel Perforation (2668)
Event Date 09/12/2018
Event Type  Injury  
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
It was reported that during a follow up appointment for a patient with post-hemorrhagic asymmetrical hydrocephalus, the doctor realized that the peritoneal catheter had exited through the anus of the patient. It was stated the catheter had perforated the intestine. The patient was well however. The catheter was explanted and the patient was connected to an external drainage system while liquid antibiotics were administered. While the patient was connected to the external drainage system, they could not stand up since the valve did not prevent overdrainage. The valve was also replaced. The patient¿s status was noted as alive; no injury.
 
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Brand NamePERITONEAL CATHETER, STANDARD, OPEN END, BARIUM IMPREGNATED, 120 CM
Type of DeviceSHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS
Manufacturer (Section D)
MEDTRONIC NEUROSURGERY
125 cremona drive
goleta CA 93117
Manufacturer (Section G)
MEDTRONIC NEUROSURGERY
125 cremona drive
goleta CA 93117
Manufacturer Contact
stacy ruemping
7000 central avenue ne rcw215
minneapolis, MN 55432
7635260594
MDR Report Key8243398
MDR Text Key132906805
Report Number2021898-2019-00025
Device Sequence Number1
Product Code JXG
Combination Product (y/n)N
Reporter Country CodeSZ
PMA/PMN Number
K792005
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional
Reporter Occupation
Type of Report Initial
Report Date 01/14/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/14/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date12/31/2019
Device Model Number23047
Device Catalogue Number23047
Device Lot NumberD73509
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received12/18/2018
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured03/02/2015
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 01/14/2019 Patient Sequence Number: 1
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