MAUDE Adverse Event Report: MEDTRONIC NEUROMODULATION ACTIVA

Model Number 37601

Device Problems High impedance (1291); Unintended Collision (1429); Low impedance (2285)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Type  Injury  

Manufacturer Narrative

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

Event Description

It was reported that there is an impedance issue the monopolar impedance are high, but the bipolar impedance are ok.In  previous programming sessions, 1 electrode was high, and 1 electrode had low impedance.Monopolar 1 was higher at 2489; today 0+1 with "low" impedance.Physician reprogrammed around those electrodes.Additional information was received from the manufacturer representative that the patient stated that he lifted a heavy piece of plywood and afterwards felt an increase in symptoms.Exploration of the implant and extension revision is planned, however, date is to be determined.

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
• Manufacturer (Section D): MEDTRONIC NEUROMODULATION; 7000 central ave ne; minneapolis MN 55432
• MDR Report Key: 12310374
• MDR Text Key: 266165383
• Report Number: 2182207-2021-01394
• 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,consum
• Type of Report: Initial,Followup
• Report Date: 08/11/2021

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: 02/28/2021
• Device Model Number: 37601
• Device Catalogue Number: 37601
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 08/11/2021
• Initial Date FDA Received: 08/11/2021
• Supplement Dates Manufacturer Received: 08/11/2021
• Supplement Dates FDA Received: 08/11/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Weight: 88