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

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).

• Brand Name: IPHONE 12, STRATA PROGRAMMABLE VP SHUNT
• Type of Device: SHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS
• Manufacturer (Section D): MEDTRONIC NEUROSURGERY
• MDR Report Key: 12059385
• MDR Text Key: 258616437
• Report Number: MW5102124
• Device Sequence Number: 1
• Product Code: JXG
• Reporter Country Code: US
• Number of Events Reported: 1
• 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 Received: 06/23/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: IPHONE 12
• Was Device Available for Evaluation?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention; Disability
• Patient Age: 44 YR
• Patient Weight: 63