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

Model Number 37612

Device Problems Improper or Incorrect Procedure or Method (2017); Low Battery (2584); Device Displays Incorrect Message (2591); Battery Problem (2885); Communication or Transmission Problem (2896); Device Operates Differently Than Expected (2913); Insufficient Information (3190)

Patient Problems Therapeutic Effects, Unexpected (2099); Shaking/Tremors (2515)

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 essential tremors, movement disorders.It was reported that the caller stated "it had not been working for some time now." caller stated the patient's wife called their hcp who referred them to patient services.When asked to clarify what wasn't working the caller stated they didn't know whether it was external equipment, internal equipment or both.Caller stated the patient was implanted for essential tremors and patient "shaked horribly" stating the patient's device was "not working at all." caller did not know further information regarding if equipment connected with ins or charging history.It was stated another family member would be calling back later that day.There was a call back later from another family member/friend.Caller said the patient kept saying they tried to charge their implant and it wasn't charging.The last time the patient charged hadn't happened "for a while." patient reported their last charging session was more than one to three months ago.Caller tried to communicate with the ins using the patient programmer and reported seeing the poor communication screen.Caller then tried to communicate using the insr and reported seeing the reposition antenna screen.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 from the manufacturing representative alleging an overdischarge of the battery.The last successful recharger was several months ago.The reason why the recharging was not maintained was due to an unrelated medical issue.Caller is currently in second prm session and will continue with patient in progress.

Manufacturer Narrative

Due to imdrf harmonization, any previously submitted device, method, result, and conclusion codes no longer apply to this event.If information is provided in the future, a supplemental report will be issued.

Event Description

Additional information was received: it was reported that they tried to interrogate the device with the recharger and 8840.There was no response.Performed overdischarge steps (60 mins timer with recharger) 3 times.The overdischarge was resolved.The patient was counseled with family to regularly recharge and follow up with doctors.The patient weight was unknown, and the information was confirmed with the physician.There were no further complications reported.

Manufacturer Narrative

Correction to show that the report should not be late.Further information was gathered that had shown the rep did not know of the e vent and the report should be submitted on time.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 stated the od was known since (b)(4) 2018.The ac adaptor box was getting warm/hot on the date of the call (b)(4) 2018.Technical services confirmed with repair that it was known/expected.There was a previous od reported on the call - no name or additional information was collected.The rep indicated the patient was withouth therapy for about 30 days.The rep stated the unrelated medical issue that was reported was a little bit of a mood disorder which was maybe interferring with recharging.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 stated the od was known since (b)(6) 2018.The ac adaptor box was getting warm/hot on the date of the call (b)(6) 2018.Technical services confirmed with repair that it was known/expected.There was a previous od reported on the call - no name or additional information was collected.The rep indicated the patient was withouth therapy for about 30 days.The rep stated the unrelated medical issue that was reported was a little bit of a mood disorder which was maybe interfering with recharging.There were no further complications reported.

Manufacturer Narrative

Due to imdrf harmonization, any previously submitted device, method, result, and conclusion codes no longer apply to this event.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.

• 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
• MDR Report Key: 7573688
• MDR Text Key: 110341910
• Report Number: 3004209178-2018-12724
• Device Sequence Number: 1
• Product Code: MHY
• UDI-Device Identifier: 00613994934611
• UDI-Public: 00613994934611
• Combination Product (y/n): N
• PMA/PMN Number: P960009
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,consum
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 10/12/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/06/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/28/2014
• Device Model Number: 37612
• Device Catalogue Number: 37612
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/12/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1