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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC NEUROSURGERY SHUNT B-M ASSY US PER 90CM SM MED SHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS

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MEDTRONIC NEUROSURGERY SHUNT B-M ASSY US PER 90CM SM MED SHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS Back to Search Results
Model Number 22017 B-M
Device Problem Appropriate Term/Code Not Available (3191)
Patient Problem Therapeutic Effects, Unexpected (2099)
Event Type  Injury  
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
It was reported the patient was implanted in (b)(6) 2018. The physician suspected the shunt was malfunctioning as the patient¿s head was enlarged following implant and the shunt was explanted. The patient¿s medical history included myelomeningocele and their status was list as alive ¿ no injury.
 
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Brand NameSHUNT B-M ASSY US PER 90CM SM MED
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 Key8123079
MDR Text Key129014173
Report Number2021898-2018-00544
Device Sequence Number1
Product Code JXG
Combination Product (y/n)N
PMA/PMN Number
K873247
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 12/01/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/01/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model Number22017 B-M
Device Catalogue Number22017 B-M
Device Lot NumberUNKNOWN
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 Received11/02/2018
Was Device Evaluated by Manufacturer? No Answer Provided
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

Patient Treatment Data
Date Received: 12/01/2018 Patient Sequence Number: 1
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