MAUDE Adverse Event Report: MEDTRONIC MEDTRONIC STRATA VALVE

Model Number STRATA

Device Problems Nonstandard Device (1420); Programming Issue (3014)

Patient Problem Pain (1994)

Event Date 03/28/2017

Event Type  Injury  

Event Description

I had a medtronic strata vp shunt replaced.Had placed on (b)(6) 2016.In and out of hospital this year.Finally had them check to see if setting would change.After reducing to leave hospital until they check, they did.Yes, the settings on this shunt would change on its own.Have pictures and video from dr's office.Yes it is recalled by fda, yet i never received noticed from my doctor's office.Other pts online have not received any notice from their drs and are suffering.Yet doctors think there is no recall because no notice.I spoke medtronic was not nice, said fda should never have recalled no big deal was in the labeling.Please help others.I have sense had my vp shunt replaced and feeling better.But others are suffering and could die.Thank you.My doctor, i do not think has taken the time to file this either.Had to have surgery to replace, not working valve.Change setting on own.

• Brand Name: MEDTRONIC STRATA VALVE
• Type of Device: MEDTRONIC STRATA VALVE
• Manufacturer (Section D): MEDTRONIC
• MDR Report Key: 6529856
• MDR Text Key: 74175867
• Report Number: MW5069424
• 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: 04/26/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 11/30/2020
• Device Model Number: STRATA
• Device Catalogue Number: 42866
• Device Lot Number: E05509
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/26/2017
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Treatment: AICD (EACH, NOT TOGETHER); AND MEDTRONIC REMOVED). ; BOSTON SCIENTIFIC CONCORD VP SHUNT (JUST REPLACED ; NADOLOL 80MG DAILY ; PACEMAKER
• Patient Outcome(s): Hospitalization; Life Threatening; Other; Required Intervention; Disability
• Patient Age: 49 YR
• Patient Weight: 89