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

Model Number 37612

Device Problems Delayed Charge Time (2586); Charging Problem (2892); Communication or Transmission Problem (2896)

Patient Problems Erythema (1840); Irritation (1941); Pain (1994); Therapeutic Effects, Unexpected (2099)

Event Date 02/24/2020

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 an implantable neurostimulator (ins).It was reported that the patient charged for the first time in february and the second time last night.Both times, the patient felt a pulse going from the ins recharger (insr) into her chest.It was not painful but felt like a throbbing/pulsing sensation, which did not feel good.The patient also said it took too long to charge the ins.The first time they charged, they waited for an hour and a half and the charging percentage barely moved.The second charging time, the patient charged for 2.5 hours and it only increased 25% with 8 coupling bars.The patient was advised to contact a rep and to try charging more frequently.No further complications were reported/anticipated.

Event Description

Information was received from a healthcare provider (hcp), via the manufacturer¿s representative (rep), who reported the patient was implanted in (b)(6) of 2020.After the device was turned on, they began charging and experienced redness and irritation at the incision site.In addition, the patient had never been able to get above 50% charged and felt a ¿radiating sensation¿ when they charged, in particular at the juncture of the extension and the implantable neurostimulator (ins).There were no factors that could have led or contributed to this.In march the patient went to the emergency room (er) where they were checked for an infection and was found not to have one.The patient was checked again in april or may for an infection and was told again they did not have an infection.The manufacturer¿s representative(rep) facilitated getting the patient a new recharger to see if that was the issue, but it didn¿t resolve any of the issues.The patient was told to try to put a towel between the recharger and their skin, but couldn¿t get a good enough connection, so it didn¿t work.The patient also always wore a t-shirt when charging, but that didn¿t help either.The issue was not currently resolved, and the hcp didn¿t have any further information.

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.

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.

Event Description

Additional information was received stating that the patient was not able to get above 50% battery level, since implant.Further discussion revealed that the patient has difficulty with tolerating recharging for a long period of time.Patient skin gets red, and it's painful when she recharges.She has been checked by 2 different hospitals for infection.Patient said issue has been going on since february.Patient recharges 3-4 times a week from 15-45 minutes.It was reviewed with the patient that it can take little over 4 hours to recharge from empty to full, the fact that she hasn't been able to recharge anymore than 1.5-2 hours since implant means that it would be difficulty to get beyond 50% ins battery level, especially since she can't tolerate recharging more than 45 minutes at best, now.It was suggested putting another layer of clothing to help with sensitivity since patient is getting 8 coupling bars.Suggested perhaps recharging more frequently than now with shorter sessions to help with sensitivity.

• 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: 9865154
• MDR Text Key: 184449364
• Report Number: 3004209178-2020-05902
• Device Sequence Number: 1
• Product Code: MHY
• UDI-Device Identifier: 00763000100360
• UDI-Public: 00763000100360
• 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
• Report Date: 09/11/2020

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: 11/28/2020
• Device Model Number: 37612
• Device Catalogue Number: 37612
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 03/19/2020
• Initial Date FDA Received: 03/23/2020
• Supplement Dates Manufacturer Received: 09/01/2020; 09/10/2020
• Supplement Dates FDA Received: 09/02/2020; 09/11/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 41 YR