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

Model Number 37601

Device Problems Display or Visual Feedback Problem (1184); Low impedance (2285); Impedance Problem (2950)

Patient Problems Discomfort (2330); Complaint, Ill-Defined (2331)

Event Date 12/13/2018

Event Type  Injury  

Manufacturer Narrative

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

Event Description

Information was received by a manufacture representative (rep) regarding an implantable neurostimulator (ins) for dystonia, movement disorders.It was reported that the rep said the hcp checked the patient's implant yesterday and they noted that the battery was at 2.7 volts, which appeared to be low per the hcp.When the rep checked the battery the day of the call they noted that the battery level was at 2.9 volts.The rep wasn't able to test at a later time to see if the battery level was still the same.The rep was to send impedances values to technical services, who weren't sure if the hcp had tested the impedances in various head positions or if the hcp did any palpation along the system.Technical services asked for the patient's impedance hx, but the rep didn't have a chance to respond.The rep had to see the hcp, so they disconnected.The patient had a pattern of ins replacement of every 11-13 months.Additional information was received from the rep stating the patient had no resolution with the issue yet, and said they had some type of sensation behind their ears where the extensions runs.They didn¿t know if it was just positioning or something else but not heating or electrical according to the doctor.Pictures of the tablet were sent in and it was stated that there was a possible short, which would explain the draw on the battery.Images sent by the rep had shown contact 11 was out of range.The doctor wanted to program away from that electrode to avoid further drain.It sounded like that short was intermittent, around the lead/extension site, since the battery rebounded.There were no further complications reported.There were no further complications reported.

Manufacturer Narrative

(b)(4).If information is provided in the future, a supplemental report will be issued.

Event Description

Additional information was received: it was reported that the rep and the neurologist didn't have any more information on the situation.It was determined not to be a short; it was a difference in the read of the tablet from one day to the next.The rep wasn't sure if the patient was requesting a new placement for stage 2 extensions due to discomfort.There were no further complications reported.

Manufacturer Narrative

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

Event Description

Additional information was received: it was reported that the cause of the impedance and battery draining issues were not determined.They said ¿probably technical error.¿ there were no further complications reported.

Manufacturer Narrative

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

Event Description

Additional information was received: it was reported that the rep didn¿t have any more information at that point and didn¿t¿ know the underlying impedance issue.There was no surgery yet, but the patient had an appointment with the doctor on (b)(6) 2019 to get it looked at by the doctor again as they wanted to get a stage 2 revision.There were no further complications reported.

Manufacturer Narrative

Medtronic, inc.(medtronic) is submitting this report to comply with 21 c.F.R.Part 803, the medical device reporting regulation.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 in the time allotted and has provided as much information as is available to the company as of the submission date this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic or its employees 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 reporting pursuant to part 803.Medtronic objects to the use of these words and others like it 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.

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: 8200516
• MDR Text Key: 131536772
• Report Number: 3004209178-2018-28444
• Device Sequence Number: 1
• Product Code: MRU
• UDI-Device Identifier: 00643169864191
• UDI-Public: 00643169864191
• Combination Product (y/n): N
• PMA/PMN Number: H020007
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 10/14/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/28/2019
• Device Model Number: 37601
• Device Catalogue Number: 37601
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 12/14/2018
• Initial Date FDA Received: 12/27/2018
• Supplement Dates Manufacturer Received: 01/07/2019; 01/07/2019; 01/07/2019; 03/11/2019; 10/14/2020
• Supplement Dates FDA Received: 01/07/2019; 01/07/2019; 01/17/2019; 03/17/2019; 10/14/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 83 YR