MAUDE Adverse Event Report: IPG MFG SWITZERLAND KINETRA; STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR

Model Number 7428

Device Problem Electromagnetic Interference (1194)

Patient Problems Therapeutic Response, Decreased (2271); Cognitive Changes (2551)

Event Date 06/17/2015

Event Type  Injury  

Event Description

It was reported that 48 hours ago the patient was going through airport security and he passed through a medical detector.After passing through the patient sat near a security archway for about 15 minutes and then was required to pass through again.The patient was hospitalized, and had gone from a fully functional brain to now not able to hold a thought; he was unable to make a sentence and does not know where he is.The patient¿s wife described the patient¿s dementia as off the chart.The patient was incoherent and has been strapped down for safety.The patient¿s device was confirmed to be on, but the settings were unknown.Loss of therapy was reported.The patient¿s wife was trying to get a hold of the patient¿s implant doctor, but the doctor was currently away; she was going to try to get the patient transferred to his city.Follow up was performed but no additional information was available.If additional information is received, a follow up report will be sent.

Manufacturer Narrative

(b)(4).

• Brand Name: KINETRA
• Type of Device: STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR
• Manufacturer (Section D): IPG MFG SWITZERLAND; route du molliau 31; tolochenaz 1131 ; CH 1131
• Manufacturer (Section G): MEDTRONIC NEUROMODULATION; 7000 central avenue ne rcw215; minneapolis MN 55432
• Manufacturer Contact: diane wolf ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635263987
• MDR Report Key: 4900086
• MDR Text Key: 6022739
• Report Number: 9614453-2015-01621
• Device Sequence Number: 1
• Product Code: MHY
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: P960009
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Consumer,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 06/19/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/08/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/14/2011
• Device Model Number: 7428
• Device Catalogue Number: 7428
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/19/2015
• Date Device Manufactured: 11/20/2009
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Other