MAUDE Adverse Event Report: MEDTRONIC MED REL MEDTRONIC PUERTO RICO ACTIVA; STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR

Model Number 37603

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

Patient Problems Depression (2361); Shaking/Tremors (2515); Cognitive Changes (2551)

Event Type  Injury  

Event Description

Additional information received reported the patient had received assistance from their doctor or manufacturer representative and their concerns were resolved.It was stated the patient had an appointment on (b)(6) 2014.Additional information received reported the cause of the event was ¿immediate post-operative.¿ it was noted the patient had given i information about their ¿temporary/transient issues¿ in the immediate post-operative period.It was stated the patient did not have any problems and they were satisfied with their state at the time of report.

Event Description

It was reported after the patient was implanted they felt shaking, they were depressed and mentally out of it and they hallucinated.It was noted, the patient was not programmed until a few weeks after the implant but the patient indicated that the unit¿s stimulation coupled with the medication contributed to it.It was noted, the patient was in withdrawal because too much of their medication was ¿taken away.¿ it was stated this occurred one year prior to report.It was stated their doctor was in the process of adjusting their medication.It was noted, the patient had essential tremor and parkinson¿s disease tremors but their doctor chose ¿to go after to parkinson¿s disease tremors.¿ it was noted they did not want to treat the essential tremor due to the patient¿s age and their health.

Manufacturer Narrative

Product id 3387s-40, lot# va048wb, implanted: 2013 (b)(6); product type lead product id 3708660, serial# (b)(4), implanted: 2013 (b)(6); product type extension product id 37642, serial# (b)(4); product type programmer, patient.(b)(4).

• Brand Name: ACTIVA
• Type of Device: STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR
• Manufacturer (Section D): MEDTRONIC MED REL MEDTRONIC PUERTO RICO; ceiba norte industrial park, r; juncos PR 00777
• 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: 3628613
• MDR Text Key: 4256236
• Report Number: 3004209178-2014-03007
• Device Sequence Number: 1
• Product Code: MHY
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P960009
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 01/24/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/14/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2014
• Device Model Number: 37603
• Device Catalogue Number: 37603
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/24/2014
• Date Device Manufactured: 09/11/2012
• 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): Other
• Patient Age: 00064 YR