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

Model Number UNKNOWN-SMR

Device Problem Mechanics Altered (2984)

Patient Problems Headache (1880); Vertigo (2134); Dizziness (2194); Ambulation Difficulties (2544)

Event Date 01/18/2018

Event Type  malfunction  

Manufacturer Narrative

Please see report number mw5075095.If information is provided in the future, a supplemental report will be issued.

Event Description

It was reported that the patient began experiencing a headache, dizziness, and feeling like his surroundings were spinning.Due to the patient being in a wheel chair, they were unable to get safely out of bed so the health careprovider (hcp) was called and an appointment scheduled.During the appointment, the shunt was checked and it was discovered the setting was at a 1 when it should have been at 2.The product was reset to 2.It was also stated that there was no explanation determined for why the setting changed.

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

Additional information was received regarding the patient being in a wheelchair.The patient¿s diagnoses included paraplegia, thoracic myelopathy, syringomyelia, a compression fracture and muscle spasms in the legs.It was stated the patient would use a transfer board to access his wheelchair.If the patient was unable to sit up without dizziness, he is unable to safely transfer to the wheelchair.In addition, the dizziness forced the patient to remain in a horizontal position with no head elevation while in bed.No external, environmental, or patient factors were identified that may have led or contributed to the setting having changed.

• Brand Name: UNKNOWN STRATAMR VALVE/SHUNT
• Type of Device: SHUNT, 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 Key: 7337604
• MDR Text Key: 102343687
• Report Number: 2021898-2018-00139
• 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: Manufacturer
• Source Type: company representative,other
• Reporter Occupation: Other
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date: 03/22/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/14/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: UNKNOWN-SMR
• Device Catalogue Number: UNKNOWN-SMR
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/20/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Removal/Correction Number: Z-1702-2017
• Patient Sequence Number: 1
• Patient Age: 59 YR
• Patient Weight: 98