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

Model Number 37603

Device Problems Electromagnetic Interference (1194); Inappropriate/Inadequate Shock/Stimulation (1574); Battery Problem (2885); Electromagnetic Compatibility Problem (2927)

Patient Problems Numbness (2415); Electric Shock (2554)

Event Date 03/11/2021

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported the tip of the plasmablade touched the implantable neurostimulator (ins) by accident, which resulted in the patient feeling numbness in their right arm and leg for five minutes.In addition, there was a big electrical shock that was felt by the patient on the opposite side of their body.The ins battery was almost depleted at 2.6 volts, which was displayed on the clinician programmer.The ins battery was replaced.The electrode and therapy impedances were read after the battery replacement, which showed same range as prior to the replacement.The issue was resolved at the time of the report.

Manufacturer Narrative

B2/h1: the initial report indicated the ins was being reported for serious injury.Per b5, the surgical intervention was taking place for ins replacement, and there were no additional surgical interventions taken related to the event.The event is still reportable for malfunction.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.The ins was being replaced for normal depletion at the time of the shocking.

• 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: 11619088
• MDR Text Key: 243932906
• Report Number: 3004209178-2021-05508
• Device Sequence Number: 1
• Product Code: MHY
• 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,foreig
• Type of Report: Initial,Followup
• Report Date: 04/27/2021

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: 04/28/2019
• Device Model Number: 37603
• Device Catalogue Number: 37603
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 03/11/2021
• Initial Date FDA Received: 04/06/2021
• Supplement Dates Manufacturer Received: 04/23/2021
• Supplement Dates FDA Received: 04/27/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention