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

Model Number 37612

Device Problems Failure to Deliver Energy (1211); Electromagnetic Compatibility Problem (2927)

Patient Problems Loss of Range of Motion (2032); Convulsion/Seizure (4406)

Event Type  Injury  

Event Description

Information was received from a patient via a manufacturer representative (rep) regarding a patient who was implanted with a neurostimulator for parkinson¿s dual.It was reported that the patient cannot have testing like an ekg, mri, ct, x-ray, eeg, or stress test because his dbs implant interfered with the results.The patient stated he is not a typical patient because if he doesn¿t take any medication before charging, he ¿feels the electricity in his brain¿; the patient can feel the electricity moving from one wire to the other.The rep reported that apart from the electrical surges in the patient¿s brain, he is also experiencing surges in other parts of his body caused by electrical and magnetic forces interfering with his device.The patient also has a metallic taste in his mouth and experiences an ¿uncomfortable feeling¿ when he is around emi.The emi issues only occur when he is not at home (photo machine at the store, cash registers, racks of computers behind the counter at stores, or electrics department in any store); he does not experience any emi affects from his microwave, refrigerator, washer/dryer, tv, computers, patient programmer, or implantable neurol ogical stimulator recharger (insr).It is unknown what diagnostics/troubleshooting were performed as it was stated that the patient has had multiple visits with his neurologist but the visits have yielded very little.It was also reported that the patient has convulsive seizures when the device is turned off, but only experiences slight tremors when it¿s on; the patient does not have epilepsy.The patient reported that his tremor medications were toxic and interfered with his dbs.It is unknown when the previously reported issues began occurring.Additional information wasreceived from the patient representative (pt rep) reporting the patient had a lot of problems being around electronics, such as not being able to check out at stores because of the computers as the interference would cause seizure-like activity.When initially asked when that had began, the caller stated it was when medtronic changed how the ins batteries were built, went from volts to milliamps, and that ever since that they had had this seizure problem.However, when patient services (pss) asked if dbs therapy was indicated for seizures, caller stated no, and then caller stated that the patient never had seizures before having the first dbs ins placed, and since after the patient was first implant they had been dealing with the seizures.The caller stated that the dbs was turned on in april of 2006, and the first seizure experience they had was in may of 2006 when they were voting, as voting had changed to using computers.The caller stated when they had been near the computer, their therapy had turned off, and when they were traveling from one location to another, they went into a seizure and they had no way of checking whether the therapy was on or off, so they had to be rushed to their neurologist for help turning therapy back on.The caller stated they no longer had a problem with therapy turning off due to interference, just that the electronics would interfere with the dbs device and then the patient would go into having a seizure.The caller stated that the only time they never experienced any problems with the seizures and procedures was if they were put under.The caller mentioned that even if the patient turned their therapy off for procedures but not be under/put to sleep, they would go into seizures.The caller stated that within the last year, the patient lost the use of their right leg for 6 weeks due to a seizure that was so severe that it depleted all cellular energy in the patient's leg, and that it took that time for the patient's cells to regenerate.The caller added that when they were having their labs drawn at the hospital, they told the facility that they couldn't be in a room with lots of electronics, and they had been told the computers were off, however, the facility forgot about the fax machine, and the fax machine interference sent the patient into a seizure.The patient was redirected to their healthcare provider to further address the issue.The caller mentioned the system had been checked several times by their hcp and even had manufacturer representative (reps) there, and all was okay with the dbs system, just that the patient's settings were so high that they were very sensitive.Based on the patient's previous experiences, the caller and patient were hesitant about what could occur with the diagnostic ultrasound of the carotid artery, and had mentioned a rep in the past informed them to request a rep in case of procedures like surgeries, and they inquired about getting in contact with a rep.Refer to manufacturer reports 3004209178-2016-08240, 3004209178-2022-16116 for related devices.

Manufacturer Narrative

Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

• Brand Name: ACTIVA
• Type of Device: STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINS
• 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: glen belmer ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 6122713209
• MDR Report Key: 15939496
• MDR Text Key: 305054598
• Report Number: 3004209178-2022-16117
• Device Sequence Number: 1
• Product Code: MHY
• UDI-Device Identifier: 00763000384357
• UDI-Public: 00763000384357
• 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,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 12/08/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/08/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/14/2022
• Device Model Number: 37612
• Device Catalogue Number: 37612
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/30/2022
• Date Device Manufactured: 08/23/2021
• 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 Sex: Male