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

Model Number 37601

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

Patient Problems Emotional Changes (1831); Dysphasia (2195); Depression (2361); Sleep Dysfunction (2517); Cognitive Changes (2551)

Event Type  Injury  

Event Description

It was reported that the patient had developed some speech problems and she could tell people had a hard time understanding her.The patient also noted that she was apathetic and bored a lot.However, the patient looked forward to social interactions with friends and neighbors and enjoyed listening.Additional information reported that the patient felt awful one year after surgery.The patient was having mood swings, sleeping way too much, grumpy, and depressed.The patient wrote that this had been going on for months and it was getting worse.It was noted that the patient¿s motor symptoms were okay, but the patient was miserable.The patient was convinced that the surgery or settings were to blame.The patient even found herself having suicidal thoughts, but figured ¿she would screw it up and make herself worse.¿ the patient began to regret having the surgery.The patient received an email from another patient who had the same surgery and was experiencing similar personality changes.The patient discovered that the settings could be causing her depression and was told to find a ¿good programmer immediately.¿ the patient made an emergency appointment with a neurologist who could adjust her settings, but he did not think the depression was related and suggested a psychiatrist and antidepressants.The patient tried a couple of antidepressants, but they made her feel worse.The patient eventually found a doctor who would adjust the settings and made an appointment.The patient stated that the doctor ¿moved her settings up to a different spot on the stems in her brain and within a few days the difference was amazing.¿ the patient had more energy, felt more sociable, and the depression was gone.The patient¿s gait was almost normal, the morning tremor in her right hand was gone, and the rigidity and slowness she got every afternoon was gone.The patient noted that she still had some speech issues; she dropped consonants or spoke too softly or quickly.

Manufacturer Narrative

Product id 3708660, serial# (b)(4), implanted: 2012 (b)(6); product type extension product id 3387s-40, lot# va0303x, implanted: 2012 (b)(6); product type lead product id 3387s-40, lot# va0303x, implanted: 2012 (b)(6); product type lead.(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: 3635004
• MDR Text Key: 3985603
• Report Number: 3004209178-2014-03276
• 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
• Report Date: 01/30/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/19/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 01/14/2014
• Device Model Number: 37601
• Device Catalogue Number: 37601
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/30/2014
• Date Device Manufactured: 07/23/2012
• 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