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

Model Number 37601

Device Problems Break (1069); Electromagnetic Interference (1194); High impedance (1291); Low impedance (2285); Therapeutic or Diagnostic Output Failure (3023)

Patient Problems Fall (1848); Ambulation Difficulties (2544)

Event Date 11/25/2019

Event Type  malfunction  

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 patient who was implanted with an implantable neurostimulator (ins) for parkinson's disease and movement disorders.It was reported that patient was having a short circuit on electrode 0 & 1 at 64 ohms and 8 & 11 at 60 ohms.Patient was programmed in voltage mode, and 3 weeks ago when the health care provider (hcp) interrogated the implant the battery was at 2.71 volts, when the hcp interrogated battery on last friday the battery had bounced back to 2.91 volts.Patient did accidently turn therapy off for a while.Hcp brought patient back in office today to reprogram, patient's balance was off.Hcp decided to switch patient to current mode.Rep wanted to know since hcp had to use 0 & 1 for programming, if going to current mode would drain the battery.It was reviewed for the rep that since impedance is measured before system delivers the programmed 3.6 ma, then ins battery would not drain, like it would have if programmed in voltage mode.Patient did report falling few weeks ago.Patient's programming is; left 0-1+ 3.6ma 90pw, 160hz right 9+10- 3.2 ma 60pw 160hz it was mentioned that the hcp got an out of regulation (oor) on the tablet when they programmed the patient on current mode.Impedances were tested and the following impedance results were reported as seen below.Left c3 774 ohms c2 735 c1 608 c0 607 03 1016 02 823 01 64 13 1021 12 826 23 920 right c11 595 ohms c10 895 c9 834 c8 595 8 & 11 60 8 & 10 936 8 & 9 920 9 & 11 922 9 & 10 1074 10 & 11 938 follow up programming was noted as below; left stn bi polar low impedance 64 01 64 8 & 11 60 patient was getting benefit.It was also reported that the physician has switched to constant current (cc) from constant voltage (cv).The hcp has tried different electrodes and patient only do well with: left: 0-1+ right 9+10- impedance: 0/1: 64 ohms 8/11: 60 ohms rep reported patient had been on cc for a week: (b)(6) 2019: ins battery voltage: 2.85v (b)(6) 2019: ins battery voltage: 2.91v.The rep indicated that the patient did not have any impedance issue until ins was moved from chest to abdomen.The rep reported that when patient was in cv, patient had fallen, but since the reprogramming to cc, patient has not fallen.

Manufacturer Narrative

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

Event Description

Additional information received from a manufacturing representative (rep) indicated the cause of the short circuit and oor message could not be determined.The short circuit was not resolved.

Manufacturer Narrative

Product id 3389s-40, lot# va03t31, implanted: (b)(6) 2012.Product type lead, product id 3389s-40, lot# va03t31, implanted: (b)(6) 2012.Product type lead.If information is provided in the future, a supplemental report will be issued.

Event Description

Additional information was received stating programming was being done to resolve the impedance issue.The patient was still having impedance issues which was draining the battery, but the patient was receiving benefit from therapy.The impedance issue had not resolved and more troubleshooting would occur at the next battery replacement.

Manufacturer Narrative

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

Manufacturer Narrative

Section d information references the main component of the system and other applicable components are: product id 3389s-40, lot# va03t31, implanted: (b)(6) 2012, product type: lead, product id 3389s-40, lot# va03t31, implanted: (b)(6) 2012, product type lead.Device code c63124 pertains to the ins (s/n (b)(6)).Patient codes: c50458, c50558 / device codes: c62973, c63124, c63214, c63047 / method: 4117 / result: 3221 / conclusion: 67 pertains to the two leads (lot # va03t31).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 on (b)(6) 2020, from a healthcare provider (hcp) via a manufacturer representative (rep).It was reported that the patient is still having the impedance issue but feels they are receiving therapy.While this might drain the battery due to their high impedance values, the patient was advised to check their battery level frequently to monitor.They were told that the patient had a dermatology procedure done (b)(6) where they cauterized the skin near the dbs burr hole site/scar.It wasn't long after that the patient ended up in the neurology clinic getting adjusted.They think the patient's leads could have been damaged, but is still being investigated.

• 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: 9535890
• MDR Text Key: 176232920
• Report Number: 3004209178-2019-24587
• Device Sequence Number: 1
• Product Code: MHY
• UDI-Device Identifier: 00763000175719
• UDI-Public: 00763000175719
• 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
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 02/12/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/31/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/14/2021
• Device Model Number: 37601
• Device Catalogue Number: 37601
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/29/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: "SEE H10...."; SEE H10
• Patient Age: 78 YR