MAUDE Adverse Event Report: MEDTRONIC PUERTO RICO OPERATIONS CO. ACTIVA; IMPLANTED SUBCORTICAL ELECTRICAL STIMULATOR (MOTOR DISORDERS)

Model Number 37601

Device Problems Vibration (1674); Electromagnetic Compatibility Problem (2927)

Patient Problems Therapeutic Effects, Unexpected (2099); Complaint, Ill-Defined (2331)

Event Date 11/28/2018

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

Information was received from a consumer regarding a patient who was implanted with a neurostimulator (ins) for dystonia and movement disorders.It was reported that the patient has been having new symptoms and they called their neurologist at the clinic and they have been accepted as a new patient.Patient said their appointment is in (b)(6) so they haven't seen her yet and do not know what to do with her so they suggested she call in.They have never heard of what she has so they recommended that.Patient said she is having sensations at her implanted ins kind of like vibrations and they never heard of that.Patient said it feels like what her phone feels like when it is on vibrate but she can just barely feel it.Patient said it does not cause discomfort, it is not a shock, later said it was a tickle.Patient said it is happening many times per hour and she clocked the times:: 12:17, 12:22, 12:28, 12:36, 12:44, 12:49, 1:00, 1:07, 1:13, 1:28, 1:34, etc.There are no recent medical tests or emi environmental exposure.Patient said it was happening she was at another healthcare provider and could feel it happening.Patient further explained that this started when she listened to an audio on book, on her phone and while listening, had the phone in her chest pocket and it sits over the implant.Patient says she could feel the person reading her book in her chest then when she took the phone out of her pocket and held it in her hand she could still feel the voice.Patient said nobody has ever told her not to put the phone near the implant.No further complications were reported or anticipated with this event.

Manufacturer Narrative

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

Event Description

Additional information received from the consumer reported nothing was done to resolve the new symptoms/sensations/vibrations at the implantable neurostimulator (ins) site as the issue resolved without action.No further complications were anticipated.

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.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: IMPLANTED SUBCORTICAL ELECTRICAL STIMULATOR (MOTOR DISORDERS)
• Manufacturer (Section D): MEDTRONIC PUERTO RICO OPERATIONS CO.; road 31, km. 24, hm 4; ceiba norte industrial park; juncos PR 00777
• MDR Report Key: 8148646
• MDR Text Key: 130653799
• Report Number: 3004209178-2018-27323
• Device Sequence Number: 1
• Product Code: MRU
• UDI-Device Identifier: 00643169529786
• UDI-Public: 00643169529786
• Combination Product (y/n): N
• PMA/PMN Number: H020007
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Type of Report: Initial,Followup,Followup
• Report Date: 10/14/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/10/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/14/2018
• Device Model Number: 37601
• Device Catalogue Number: 37601
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/14/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 66 YR
• Patient Weight: 63