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

Model Number 37612

Device Problems Overheating of Device (1437); Delayed Charge Time (2586); Charging Problem (2892); Communication or Transmission Problem (2896)

Patient Problems Erythema (1840); Irritation (1941); Swelling (2091); Burning Sensation (2146); Discomfort (2330); Skin Inflammation (2443)

Event Date 05/22/2019

Event Type  Injury  

Manufacturer Narrative

Concomitant medical products: product id: 3708660, serial #: (b)(4), implanted: (b)(6) 2015, product type: extension.Product id: 3708660, serial #: (b)(4), implanted: (b)(6) 2015, product type: extension.Other relevant device(s) are: product id: 3708660, serial/lot #: (b)(4), ubd: 01-oct-2018, udi #: (b)(4).Product id: 3708660, serial/lot #: (b)(4), ubd: 08-dec-2018, udi #: (b)(4).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).It was reported the patient was implanted the day prior.Poor coupling/zero coupling boxes was reported.When asked, the caller stated the health care professional (hcp) gave the go-ahead to charge over the post-procedure incision.The caller stated the patient had a small bandage/tegaderm over the device.The caller stated they were able to interrogate the ins with the clinician programmer without issue.The caller said the ins may be a "little deep" but he seemed not worried about the depth.Repositioning the antenna did not resolve the issue.The caller called back and stated there was some swelling so they let the patient go home and would give them a few days to rest.The caller stated the ins was around 75% and inquired about recharging intervals to see how much time they had until the ins would need to be charged: left gpi: c+ 2- 2.2 ma, 210 pw, 150 rate, 610 ohms (from electrode impedance measurement) right gpi: c+ 10-2.2 ma, 100 pw, 150 rate, 824 ohms (from electrode impedance measurement) 24 hours/day full to 25% 2.92 weeks, full to empty 3.89 weeks it was calculated roughly with these settings and ins currently at 75%, ins would likely be depleted in about 2 weeks.Additional information received from the manufacturer¿s representative (rep), which was confirmed by the healthcare provider (hcp), reported their swelling wasn¿t resolved yet, so they were waiting to see if the issue resolved.No further complications were anticipated.Additional information was received from the rep reporting that the it is taking the patient 4 hours to charge from low to 50%.They had a pocket revision done on (b)(6) 2019 and another rep was at the case and a revision was done on (b)(6) 2019.The pocket revision was done due to patient unable to charge.Post pocket revision the charging was fine.Caller reported patient indicated she feels heat along the extension line, reports the extension is not new, patient had those extensions.Caller reports impedances are fine.The patient, who has severe dystonia, went from a non-rechargeable unit to a rechargeable unit due to normal battery depletion.Surgery went well with no issues and was able to get good coupling.During the recharge the patient became uncomfortable and feels that heating sensation coming back in the ear along the extension.After recharge, the patient experienced noticeable redness and blistering in the exact same area where heating was experienced.Cannot confirm if blisters and redness are directly related to the recharging but occurred since last time recharging was done on (b)(6) 2019.Caller also noted he had done antenna locate and is able to get 4 bars.They confirmed later on that they decided to replace the rechargeable device with a non-rechargeable device at a later date.

Manufacturer Narrative

Analysis of the implantable neurostimulator (ins) (s/n (b)(4) found the battery had reduced capacity due to overdischarge.The ins was received with no telemetry and no output from any electrode pair.Telemetry was restored after a short physician mode recharge.After telemetry was restored and a full normal recharge, the ins passed functional testing.According to the trace report taken from the ins, the last recharge while implanted took place on (b)(6) 2019 and the battery was charged to 3.745 volts.On (b)(6) 2019 the battery had depleted to the "lock" mode (<(><<)>3.575 volts).Subsequently, the battery depleted to an over discharged state prior to being received for analysis.If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

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

Event Description

Additional information was received indicating the patient was having a revision.They were switching from a rc to a pc ins on (b)(6) 2019.It was also reported they were recharging on (b)(6) 2019 and got the battery up to 50%.It was then that they were waiting to follow up with the surgeon and rep to see exactly what the patient was experiencing.It was determined at this time that heating was occurring as soon as the battery was coupled and recharging started.Recharging was advised not to continue due to ongoing irritation.The cause was undetermined.The issue had not resolved at the time of follow up.

Manufacturer Narrative

D2: please note that this device was used in an off-label manner as it was implanted for dystonia.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: 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: 8675947
• MDR Text Key: 147243275
• Report Number: 3004209178-2019-11070
• Device Sequence Number: 1
• Product Code: MRU
• UDI-Device Identifier: 00643169864238
• UDI-Public: 00643169864238
• 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
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 11/10/2020

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: 12/28/2019
• Device Model Number: 37612
• Device Catalogue Number: 37612
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/24/2019
• Initial Date Manufacturer Received: 06/05/2019
• Initial Date FDA Received: 06/06/2019
• Supplement Dates Manufacturer Received: 06/07/2019; 09/30/2019; 11/10/2020
• Supplement Dates FDA Received: 06/18/2019; 10/10/2019; 11/10/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 43 YR
• Patient Weight: 112