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

Model Number 37612

Device Problems Energy Output Problem (1431); Patient Device Interaction Problem (4001)

Patient Problems Pain (1994); Therapeutic Effects, Unexpected (2099); Therapeutic Response, Decreased (2271); Complaint, Ill-Defined (2331); Neck Pain (2433); Shaking/Tremors (2515)

Event Date 02/26/2020

Event Type  malfunction  

Manufacturer Narrative

Concomitant medical products: product id: 37751, serial#: (b)(4), product type: recharger.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 an implantable neurostimulator (ins).It was reported that the patient saw his healthcare professional (hcp) for normal setting adjustments.He went home and was able to charge his ins on monday and tuesday, but on wednesday and thursday, the ins recharger (insr) said the implant was already full.The patient said the insr said the implant was full three days in a row, which he didn¿t think was the case.The patient said he used to have to charge every day and at the appointment, his settings got turned higher.The patient stated that he was not getting any "power" to his head and his tremors had returned.The insr showed that the ins was on.The patient was warmed to repair to get new equipment but was told if the new equipment dint solve the issue, he would need to see his hcp.

Event Description

Additional information was received from the manufacturer representative (rep).It was reported that in the past week, patient has noticed a shorter charging time and patient has also noticed that he is not getting the therapy, further stating that in the past week, patient had noticed an increase in tremor, parkinson's disease (pd) symptoms and feels like stimulation is off when its on.It was reported that before patient would charge for 20-30 minutes and now it's only taking patient 5 minutes or less to charge.Patient noticed the recharger reached 100% very quickly.Rep reported impedance has checked out fine-within normal limit.Rep reported ins shows 100% charged level.It was reported that the patient would take about 30-50 mins on each charging sessions.Reports on the session report: 2/28: charged 3 mins, 3 mins and 6 mins, all 100% charged.3/1: 1-2 mins3/2: 5 mins with excellent coupling 12/18: 35 mins charging from 75-100% with excellent coupling.It was reported that patient should be charging longer period of time with a hi gher setting, left gpi: 5v and right gpi 5.1v.It was reported that the patient keeps stimulation on 24/7.Patient received had a replacement a new recharger the previous saturday.Recharging statistics were obtained.It was reported that the patient has been using group c for the past week.Recharging interval calculation obtain: group c left gpi: 5.0v/110pw/10hz.Therapy impedance: 902 ohms right gpi: 5.1v/130pw/10hz.Therapy impedance: 709 ohms using 60hz: 25%: 13.88 days and 0%: 2.64 weeks.Rep reported that this is a new group.It was reported that patient was on group b before it was switched to group c.Recharging interval calculation obtain: group b:left gpi: 1.4.0v/180pw/125hz.Therapy impedance: 900 ohms2.4.7v/180pw/125hz.Therapy impedance: 1022 ohms.Right gpi: 1.3.5v/90pw/125hz.Therapy impedance: 725 ohms25%: 7.42 days and 0%: 9.89days.It was reported that when the rep reprogrammed patient to this group to obtain the therapy impedance, patient indicated he felt much better.The drop in rate and pw on group c was reviewed.Patient was redirected to the health care provider (hcp).Patient also mentioned on random days, does not matter position or location, patient would feel normal and then all of a sudden he would feel pain on his neck and shoulder and feet.Rep reported that this happened twice when patient was laying down and in pool therapy.This happened on (b)(6) 2020 and (b)(6) 2020.Patient indicated this can happen for 30-45 mins.

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 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: 9780793
• MDR Text Key: 184911666
• Report Number: 3004209178-2020-04508
• Device Sequence Number: 1
• Product Code: MHY
• UDI-Device Identifier: 00643169864238
• UDI-Public: 00643169864238
• Combination Product (y/n): N
• PMA/PMN Number: P960009
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Type of Report: Initial,Followup
• Report Date: 03/05/2020

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: 08/14/2020
• Device Model Number: 37612
• Device Catalogue Number: 37612
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 02/28/2020
• Initial Date FDA Received: 03/03/2020
• Supplement Dates Manufacturer Received: 03/03/2020
• Supplement Dates FDA Received: 03/05/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 59 YR