MAUDE Adverse Event Report: MEDTRONIC NEUROSURGERY MEDTRONIC STRATAMR ; SHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS

Model Number 42955

Device Problems Nonstandard Device (1420); Physical Resistance/Sticking (4012)

Patient Problems Fatigue (1849); Headache (1880); Pain (1994); Collapse (2416)

Event Date 12/07/2016

Event Type  Injury  

Event Description

Had a surgery to install a cerebral shunt in my head to drain fluid (had a blockage which caused fluid buildup / hydrocephalus).Device was medtronic stratamr ref# 42955, lot # e18556, serial number (b)(4).Device had issues from the start - multiple ct scans showed that the ventricles were always collapsed after installation of this device because way too much fluid was being drained, regardless of how device was set.Had serious side effects, including brutal headaches (worst ice cream brain freeze ever, all the time, only massive amounts of sleep would help it); "balance issues (felt like i was on a boat in a storm, fell a lot), sometimes severe enough i felt unsafe driving, severe pain in head when coughing or sneezing (felt like i was hit in the head with a baseball bat, and pain would persist), extreme crippling fatigue (would sleep 10-12 hrs each night, and always sleep through at least one day on the weekend, did not get my 40 hours at work more than 3 or 4 times in the past 2 1/2 years), light sensitivity (could not go outside without sunglasses, pain when looking at computers or screens), issues with movies (would usually end up in bed in agony for 1-2 days if we went to the theatre).I know this unit was recalled, but it was apparently for sticking shut - ct scans and symptoms were consistent with mine repeatedly sticking open (we think), which is a different failure mechanism.Dr was very concerned about chances of injury to the brain with insufficient fluid to pad it.Also note that device would not respond consistently to medtronic's device to measure or change the settings on it, so we and the surgeon are not ultimately sure where this was set since it frequently did not react as expected to the device to measure its settings or adjust it.Ultimately had a second surgery to replace this unit in (b)(6) 2019 and all of the symptoms listed above went away immediately following replacement of this unit.Following the second surgery last month (and the immediate complete improvement), i spoke with the surgeon's office and they encouraged me to file a report with you in case other people are suffering as a result of the same failure mechanism.Now, borderline diabetes because i have been unable to exercise meaningfully for several years.Replaced the medtronic device with a certs valve.Fda safety report id# (b)(4).

• Brand Name: MEDTRONIC STRATAMR
• Type of Device: SHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS
• Manufacturer (Section D): MEDTRONIC NEUROSURGERY
• MDR Report Key: 8865453
• MDR Text Key: 153846510
• Report Number: MW5088788
• Device Sequence Number: 1
• Product Code: JXG
• Combination Product (y/n): N
• 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: 08/01/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/05/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 42955
• Device Lot Number: E18556
• Was Device Available for Evaluation?: No
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 47 YR
• Patient Weight: 100