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

Model Number 37612

Device Problems Intermittent Continuity (1121); Failure to Deliver Energy (1211); Unintended Collision (1429); Use of Device Problem (1670); Delayed Charge Time (2586); Charging Problem (2892)

Patient Problems Shaking/Tremors (2515); Ambulation Difficulties (2544); Paresthesia (4421); Insufficient Information (4580)

Event Date 08/07/2022

Event Type  malfunction  

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

It was reported that since sunday, the implantable neurostimulator (ins) has turned off 3-4 times and that their right hand is tingly and balance is off.The caller stated the patient mentioned they had a fall since sunday.Technical services (ts) made outbound call to patient who confirmed therapy has turned off 3-4 times this week.The patient stated that it can take 4-5 hours or longer to get battery up to 50% but hasn't been able to get ins passed 75% full.Ts reviewed coupling bars and stated the more bars (6-8) will be most efficient charging time but if lower than that charging could end up being all day especially if battery is at 0%.Ts reviewed that when ins is at 0%, ins will shut off and the patient will be without therapy.Ts had the patient start charging session to check therapy status and battery level; ins was on/ok, ins battery level at 50% full, charging up to 75%.The patient originally saw coupling at 0 bars, then it moved to 4 bars and eventually got it up to 8 bars.The patient mentioned having some memory problems and remembering to charge the ins.Ts suggested to put a reminder in his cell phone to check the ins battery level.Since patient had difficulty keeping the recharger in place, ts will order sticky patches for the patient to see if that works better for him.

Event Description

Additional information was received from the patient that, since last year, the ins keeps turning off for no reason, "messing up" their shaking on their right side.It starts happening on it's own, one time it was 3 days, another time 2 weeks, but when it happens maybe a quarter of the battery is down.Patient said they normally recharge for about 40 minutes every 3 to 4 days, and they use the sticky patches.Patient said they recently were in detox and their ins was fully charged before they went in but they were not able to recharge the 10 days they were there and on easter the patient collapsed and was taken to the er.Patient's spouse brought the recharging equipmentthere and er staff turned the ins back on.Patient asked why therapy turning off could cause a collapse and agent redirected to healthcare provider (hcp).During the call, patient was able to start recharging successfully with 8 black coupling boxes.Patient stated the last time they charged was 5 days ago and the ins battery icon was blinking between 75-100 percent.Reviewed to keep track of the date and time, if it turns off for no reason and let hcp know this has been happening.Reviewed the patient can start using the programmer more often to check the status and to be ready if they need to turn therapy back on.Patient confirmed they do not accidentally press the white button and they are not accidentally turning therapy off.

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 ESSENTI
• Manufacturer (Section D): MEDTRONIC PUERTO RICO OPERATIONS CO.; road 31, km. 24, hm 4; ceiba norte industrial park; juncos PR 00777
• Manufacturer (Section G): MEDTRONIC PUERTO RICO OPERATIONS CO.; road 31, km. 24, hm 4; ceiba norte industrial park; juncos PR 00777
• Manufacturer Contact: glen belmer ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 6122713209
• MDR Report Key: 15234937
• MDR Text Key: 297986915
• Report Number: 3004209178-2022-10394
• Device Sequence Number: 1
• Product Code: PJS
• UDI-Device Identifier: 00643169864238
• UDI-Public: 00643169864238
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P960009
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 07/17/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/16/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/28/2020
• Device Model Number: 37612
• Device Catalogue Number: 37612
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/19/2023
• Date Device Manufactured: 06/12/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 61 YR
• Patient Sex: Male