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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC NEUROSURGERY IPHONE 12, STRATA PROGRAMMABLE VP SHUNT SHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS

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MEDTRONIC NEUROSURGERY IPHONE 12, STRATA PROGRAMMABLE VP SHUNT SHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS Back to Search Results
Model Number IPHONE 12
Device Problem Electromagnetic Interference (1194)
Patient Problems Fatigue (1849); Headache (1880); Tinnitus (2103); Visual Impairment (2138); Confusion/ Disorientation (2553)
Event Date 05/24/2021
Event Type  Injury  
Event Description
I have a programmable vp shunt. I purchased an (b)(6) on (b)(6) 2020. Since then, my vp shunt settings have changed 3 times leading to over drainage of cerebral spinal fluid (csf). This produced symptoms of severe headache, fatigue, difficulty concentrating, deafening pulsatile tinnitus, worsened double vision, a pulling sensation of my brain. The nurse practitioner who previously reprogrammed the shunt had me meet with my ucsf neurosurgeon on (b)(6) 2021. In this visit, my neurosurgeon not only reprogrammed my shunt, but also tested the strength of the magnet in the (b)(6) with the compass that is included with the medtronic programmable shunt clinician kit. The compass had an immediate reaction to the strength of the magnet. The neurosurgeon's (b)(6) 2021 report stated that assessment/plan "her shunt setting was found to be at lower pressure setting which confirms her concerns of over drainage. We changed it back to 1. 5. There is some concern that her (b)(6), which contains an induction magnet, may have caused her settings to change. She will talk to apple about further options to mitigate the risk of the phone changing her valve setting. The (b)(6) does not include, or display, a warning label that the product contains strong magnets that may interfere with medical devices. I had a (b)(6), which did not interfere with my vp shunt. I was required to purchase an (b)(6) when i purchased a watch to detect falls. Fda safety report id # (b)(4).
 
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Brand NameIPHONE 12, STRATA PROGRAMMABLE VP SHUNT
Type of DeviceSHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS
Manufacturer (Section D)
MEDTRONIC NEUROSURGERY
MDR Report Key12059385
MDR Text Key258616437
Report NumberMW5102124
Device Sequence Number1
Product Code JXG
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Patient
Type of Report Initial
Report Date 06/16/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/23/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberIPHONE 12
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No Answer provided
Was the Report Sent to FDA?
Event Location No Information
Was Device Evaluated by Manufacturer?
Is the Device Single Use?
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage

Patient Treatment Data
Date Received: 06/23/2021 Patient Sequence Number: 1
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