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

Model Number 37612

Device Problems Inappropriate/Inadequate Shock/Stimulation (1574); Human-Device Interface Problem (2949); Insufficient Information (3190)

Patient Problems Choking (2464); Electric Shock (2554); Insufficient Information (4580)

Event Date 09/16/2020

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 the first part of the patient's dbs implant surgery, the implanting healthcare provider (hcp) ran the lead to the back of the patient's neck.The patient went back a week later to install the battery but the implanting hcp was unavailable so another hcp implanted the battery.The patient reported the hcp that implanted the battery made the wire that goes down the neck not long enough and the wires were hooked up backwards.The patient stated there are many times they feel it is choking them, changing their voice drastically and they do not get as loud.Patient also stated when they eat grainy foods, it causes them to sneeze because their throat is trying to clear it out.The patient met with that hcp a week later to turn on the implant.The patient told the hcp that something wasn't right.The patient said the hcp told them this should be the right hand but the patient said it was the left hand.Patient stated the hcp should have listened more closely.The patient met with a mdt rep who told them someone crossed wires on them but the rep switched them around.When the patient went to bed they thought they were having a heart attack.The patient was feeling shocked in their right arm.The patient used their equipment to shut therapy off.The patient was sent to another hcp that told them they could reinsert a new wire but the patient chose not to do another surgery.The patient reported 2 weeks after that they went back in and the rep reset all the numbers.The patient expressed appreciation for their therapy stating it was working good now.Additional information was received from the manufacturer representative (rep) reporting this occurred during a follow up programming session with the managing neurologist.The rep was present.The rep reported this was a programming and lead configuration issue and not related to device failure or other issues with the system.Additional information was received from the manufacturer representative (rep) reporting he confirmed that he was unaware of the shocking that the patient reported.He did have programming sessions with the patient, but not informed of that shocking that had been reported by the patient.

• 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: 13537055
• MDR Text Key: 296346396
• Report Number: 3004209178-2022-02074
• Device Sequence Number: 1
• Product Code: PJS
• UDI-Device Identifier: 00763000100360
• UDI-Public: 00763000100360
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 02/15/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/15/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/28/2020
• Device Model Number: 37612
• Device Catalogue Number: 37612
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/26/2022
• Date Device Manufactured: 01/30/2020
• 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: 70 YR
• Patient Sex: Male