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

Model Number 42965

Device Problems Nonstandard Device (1420); Mechanical Jam (2983); Positioning Problem (3009); Appropriate Term/Code Not Available (3191)

Patient Problem Headache (1880)

Event Date 07/27/2018

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported the hydrocephalus patient was experiencing headaches and went to the hospital.A scan determined there was overdrainage with the device.The device was adjusted to 1.0.The following day, the again experienced headaches and the physician tried to adjust the device again.This time, the physician was unable to adjust the device.At the time of this report, the device was still implanted, and the patient was doing well with a slight headache.The physician was to attempt an adjustment in the future.The patient¿s status was noted as alive ¿ no injury.

Manufacturer Narrative

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

Event Description

Additional information received reported the cause of the inability to adjust the valve was that the physician had used the incorrect magnet.The physician used another magnet and could easily adjust the valve.The patient still had some headaches, but after adjusting the valve a few times, this did not change.The physician confirmed the valve was working fine and remained implanted.The cause of the headaches was still unknown.

Manufacturer Narrative

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

• Brand Name: STRATAMR VALVE, REGULAR
• 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: 7750293
• MDR Text Key: 116402665
• Report Number: 2021898-2018-00387
• Device Sequence Number: 1
• Product Code: JXG
• Combination Product (y/n): N
• Reporter Country Code: BE
• PMA/PMN Number: K152700
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Reporter Occupation: Other Health Care Professional
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup
• Report Date: 10/04/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/05/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 42965
• Device Catalogue Number: 42965
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/08/2018
• 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