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

Model Number 37602

Device Problems High impedance (1291); Unexpected Therapeutic Results (1631); Defective Component (2292); Insufficient Information (3190)

Patient Problems Blurred Vision (2137); Visual Impairment (2138); Therapeutic Response, Decreased (2271); Shaking/Tremors (2515); Ambulation Difficulties (2544)

Event Type  malfunction  

Manufacturer Narrative

Continuation of medical devices: product id 3387-40 lot# l74288, implanted: (b)(6) 2000 product type lead.Information references the main component of the system.Other relevant device(s) are: product id: 3387-40, serial/lot #: (b)(4), ubd: 02-dec-2003, udi#: (b)(4).If information is provided in the future, a supplemental report will be issued.

Event Description

Information was received from a healthcare professional via a manufacture representative (rep) regarding an implantable neurostimulator (ins) for the treatment of essential tremor and movement disorders.It was reported an impedance check was done on (b)(6) 2018 to see if the patient could have an mri for a potential new lead placement.The impedances showed electrode 3 was out, thus an mri was not done.C0 1236 ohms c1 3014 c2 841 c3 40k 01 3671 02 1529 03 40k 12 3281 13 40k 23 40k ohms group impedance 851 ohms it was reported the lead issue was noted about a year ago.The patient was having worse tremor control and had more trouble walking.The patient's visit with the health care professional (hcp) was in (b)(6) 2018 and it was noted the patient's symptoms were getting worse with gait and balance the last several years.It was reported the patient was originally programmed case and 3 at 130hz, 90pw at 3.5 volts.When the patient was switched to case and 0, the patient experienced diplopia, with case and 1 the patient had blurry vision.The patient was then put back to the original setting with c and 3 at 3.6 volts.The patient was referred to the health care professional (hcp) for ins replacement and possible lead replacement.No further complications were reported or anticipated.

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

• 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 PUERTO RICO OPERATIONS CO.; road 31, km. 24, hm 4; ceiba norte industrial park; juncos PR 00777
• Manufacturer Contact: lisa woodward clark ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635263920
• MDR Report Key: 7743117
• MDR Text Key: 116722547
• Report Number: 3004209178-2018-17256
• Device Sequence Number: 1
• Product Code: MHY
• UDI-Device Identifier: 00613994761057
• UDI-Public: 00613994761057
• 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: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 10/04/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/02/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/14/2017
• Device Model Number: 37602
• Device Catalogue Number: 37602
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/08/2018
• Date Device Manufactured: 12/15/2015
• 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