MAUDE Adverse Event Report: MEDTRONIC PUERTO RICO OPERATIONS CO. ACTIVA

Model Number 37601

Device Problems Electromagnetic Interference (1194); Failure to Deliver Energy (1211); Battery Problem (2885)

Patient Problems Lethargy (2560); Insufficient Information (4580)

Event Date 09/09/2021

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported that the patient's implantable neurostimulator (ins) was turned off sometime following (b)(6) 2021 visit.The ins has been off until (b)(6) 2021.The patient's ins was at 2.83v in (b)(6) 2021 and is now at 2.63v today.The manufacturer representative (rep) was concerned about why the battery depleted so quickly if the ins was off.The rep also mentioned that patient travels a lot and does not avoid security scanners.The patient doesn't use the patient programmer (pp) to check their device regularly.Therapy doesn't seem as good as before last appointment ((b)(6) 2021).The plan is to replace the ins in the next couple months since the ins is getting close to elective replacement indicator (eri).Impedances were taken today and all appeared normal.Additional information was received from a manufacturer representative (rep) reporting that the ins replacement is due to eri.

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 the patient programmer was showing the eri screen.The caller repeated information regarding the patient's therapy having had been turned off for 6 months, adding that the patient was lethargic during that time.The caller stated that the therapy was turned on at an office visit, and that the office staff could tell the therapy was turned on when the patient walked out of the office.However, the caller stated that the patient continued to feel really lethargic and "just not himself." the caller noted that the patient seemed like they had gotten worse.Agent had the caller check therapy status during the call, and they confirmed therapy was turned on.The ins was in the eri status at 2.51 v.Agent reviewed meaning of eri.The therapy parameters were as follows: group c was active, 3.1 for left side, and 3.0 for right side.The caller thought the patient had "high settings" and asked how much time the patient had until the ins would need to be replaced.Agent reviewed eos voltage, and advised the caller to monitor ins battery voltage with the patient programmer.The patient asked how to power off the patient programmer.Agent reviewed requested information.The caller was redirected to the patient's healthcare provider to report eri status and to further address the situation.

• Brand Name: ACTIVA
• 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: 12497959
• MDR Text Key: 272276808
• Report Number: 3004209178-2021-14124
• Device Sequence Number: 1
• Product Code: MHY
• UDI-Device Identifier: 00643169864191
• UDI-Public: 00643169864191
• 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: Consumer
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 01/05/2022

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: 03/28/2020
• Device Model Number: 37601
• Device Catalogue Number: 37601
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 09/09/2021
• Initial Date FDA Received: 09/20/2021
• Supplement Dates Manufacturer Received: 12/23/2021
• Supplement Dates FDA Received: 01/05/2022
• Date Device Manufactured: 10/11/2018
• 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: 60 YR
• Patient Sex: Male