MAUDE Adverse Event Report: MEDTRONIC PUERTO RICO OPERATIONS CO. ACTIVA; STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR

Model Number 37603

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

Patient Problems Muscular Rigidity (1968); Pain (1994); Complaint, Ill-Defined (2331); Dyskinesia (2363); Cognitive Changes (2551); Confusion/ Disorientation (2553)

Event Type  Injury  

Event Description

It was reported that during the call the patient had seemed confused.The patient and his wife were having a ¿rough time¿ and he had device turned on the morning of the date of this report for the first time.The patient had come into possession of the controller and read though the handbook.The patient was having some delirium in the midst of dyskinesia episode.Several implantable neurostimulator (ins) checks were done and showed the ins was fully charged/brand new and should provide a good service life.The patient was in agony, his pain level had gone up since the unit had been installed.The patient had pain in his right and left leg which had started about a year prior to the date of this report.The patient had parkinson¿s but had not had a tremor, he had a tightening of the muscles in his thighs and that caused pain and it had been developing over a couple of years and that was the reason for the deep brain stimulator system to control his pain.The patient thought his wife was causing his pain but the only thing she could do was shut the device off.The patient had left the healthcare professionals at noon on the date of this report and they were thrilled because his pain was better then he had taken his noon dose of sinemet and started having extreme dyskinesia where he had kind of gone into an altered state and his pain was unbearable, it was impossible to really know.The patient was due for his 3 pm sinemet dose, the patient had expressed concern for double dose and the patient¿s wife confirmed the healthcare professional had given them instructions to continue regular medication dose.They were going to discuss the first 24 hours on the day following the date of this report with their healthcare professional and they would decide if the patient can cut back on medications or leave them as is for a while.It was stated that ¿yes you are having more effect because your medications are the same and now you have the stimulation on top of that causing you to have dyskinesia worse than usual.¿ no outcome was provided.Further follow-up is being conducted to obtain this information.If additional information is received a supplemental report will be submitted.

Manufacturer Narrative

Concomitant medical products: product id: 3389s-40, lot# va0nesh, implanted: (b)(6) 2014, product type: lead.Product id: 37642, serial# (b)(4), product type: programmer, patient.Product id: 3708660, serial# (b)(4), implanted: (b)(6) 2014, explanted: product type: extension.(b)(4).

• Brand Name: ACTIVA
• Type of Device: STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR
• Manufacturer (Section D): MEDTRONIC PUERTO RICO OPERATIONS CO.; road 31, km. 24, hm 4; ceiba norte industrial park; 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: 4503250
• MDR Text Key: 5350992
• Report Number: 3004209178-2015-02732
• 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: 01/21/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/10/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 03/14/2016
• Device Model Number: 37603
• Device Catalogue Number: 37603
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/21/2015
• Date Device Manufactured: 09/22/2014
• 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: 00069 YR