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

Model Number 7428

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Headache (1880); Nausea (1970); Anxiety (2328); Cognitive Changes (2551)

Event Date 10/25/2010

Event Type  Injury  

Event Description

It was reported the patient had increased severity of obsessive compulsive disorder symptoms due to serotonin-noerpinephrine re-uptake inhibitor stop prior to surgery to prevent hemorrhage.The patient had more anxiety, more severe compulsions and obsessions.The patient¿s medications were titrated down for anafranil.The patient also had a headache and nausea.A scan without contrast results was done and was normal.Dafalgan and brufen were given as needed.Depakine 300 mg per day, mirtazapine 30 mg per day, inderal 40 mg twice daily, and redomex 25 mg twice per day were administered.Additional medication intervention included neurofen, stilnoct, and aparanax.The event resulted in in-patient hospitalization.The event was noted as resolved without sequelae.The event was not related to the device and possible related to the procedure.Additional information reported zyprexa was increased.Additional there was a medication adjustment with seroquel, etumine, and temesta.

Manufacturer Narrative

Concomitant products: product id 7428, serial# (b)(4), product type: implantable neurostimulator.Product id: 7428, serial# (b)(4), product type: implantable neurostimulator.(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: 4184682
• MDR Text Key: 18795685
• Report Number: 9614453-2014-02552
• Device Sequence Number: 1
• Product Code: MFR
• Combination Product (y/n): N
• Reporter Country Code: BE
• PMA/PMN Number: H050003
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Study,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 09/25/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/20/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 03/14/2012
• Device Model Number: 7428
• Device Catalogue Number: 7428
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/25/2014
• Date Device Manufactured: 09/15/2010
• 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