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 Bone Fracture(s) (1870); Therapeutic Effects, Unexpected (2099); Dysphasia (2195); Depression (2361); Irritability (2421); Choking (2464); Cognitive Changes (2551)

Event Type  Injury  

Event Description

Additional information received reported that the patient¿s behavioral changes, speaking and choking had nothing to do with their deep brain stimulator.It was noted that it was being handled in a different manner.

Manufacturer Narrative

(b)(4).

Event Description

It was reported that in order to control the patient¿s parkinson¿s disease tremors stimulation had to be turned up high but that resulted in the patient barely being able to speak.The patient slurred like he was drunk and had choking issues.The patient was never able to go off medication as he had been promise prior to surgery.The patient had changes in behavior after surgery also.The healthcare professional had been treating the patient for depression as well.It was noted that the patient had lost his job after surgery and the patient¿s father had bipolar issues.The deep brain surgery had been in 2010.The patient¿s wife was concerned about the patient¿s safety.The patient had depression since the original implant, he was on 2 depression medications which had made him suicidal.The depression continually gets worse each time they had increased the 2 oral medications.The patient had also developed behavioral changes which included obsessive compulsive disorder, hermit, reclusive, paranoia, delusions, insensitive, no filter when he speaks to people, domineering, rage issues especially when driving, and violence.The patient has also broken things and broken his own ribs in one of his rage fits while breaking things.The patient was aggressive with his children.The patient had moved out of the house and would not speak to his wife.The patient had always been loving, kind and respectful but all that had gradually begun to change since the deep brain stimulator was originally implanted but specifically when oral depression medication was introduced.Reference manufacturer¿s report number: 3004209178-2015-08285 for patient¿s current system.

Manufacturer Narrative

Concomitant medical products: product id 3387s-40, lot# v479548, implanted: (b)(6) 2010, product type: lead; product id 3387s-40, lot# v479548, implanted: (b)(6) 2010, product type: lead; product id 37085-60, serial# (b)(4), implanted: (b)(6) 2010, product type: extension; product id 37085-60, serial# (b)(4), implanted: (b)(6) 2010, product type: extension.(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: 4742823
• MDR Text Key: 5777293
• Report Number: 3004209178-2015-08291
• 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,Health Professional,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 04/09/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/01/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 09/28/2011
• Device Model Number: 37601
• Device Catalogue Number: 37601
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/11/2015
• Date Device Manufactured: 04/13/2010
• 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): Life Threatening; Other
• Patient Age: 00054 YR