MAUDE Adverse Event Report: MEDTRONIC VP SHUNT

Lot Number STRATA

Device Problem Self-Activation or Keying (1557)

Patient Problem Complaint, Ill-Defined (2331)

Event Date 06/20/2015

Event Type  Injury  

Event Description

I reported a failure of this device earlier this week.The dr reset the device and it has failed again.My daughter has a medtronic strata vp shunt in her brain.The device is only supposed to change performance level after adjustment with a medical magnet tool.The device has randomly changed its setting twice now in about a week.The only remedy to this situation is brain surgery to remove the defective valve and replace it.Not doing so could result in severe injury or death.

• Brand Name: VP SHUNT
• Type of Device: VP SHUNT
• Manufacturer (Section D): MEDTRONIC
• MDR Report Key: 4875131
• MDR Text Key: 16992204
• Report Number: MW5043278
• 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: 06/22/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/22/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Lot Number: STRATA
• Patient Sequence Number: 1
• Treatment: MULTIVITAMINS; VITAMIN D; PROZAC; OXYCODONE; ZOFRAN
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 18 YR
• Patient Weight: 100