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

Model Number 37601

Device Problems Material Deformation (2976); Adverse Event Without Identified Device or Use Problem (2993)

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

Event Date 05/01/2021

Event Type  Injury  

Manufacturer Narrative

Other relevant device(s) are: product id 3708640 lot# serial# (b)(4) product type extension product id 3708640 lot# serial# (b)(4) product type extension.Other relevant device(s) are: product id: 3708640, serial/lot #: (b)(4), ubd: 17-jan-2017, udi#: (b)(4); product id: 3708640, serial/lot #: (b)(4), ubd: 17-jan-2017, udi#: (b)(4).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 caller stated this had happened twice in which the patient had an ekg performed with a doctor a year and a half ago and again yesterday as the patient had developed unrelated symptoms in which they had a cough and hadn't felt good, in which they were told the patient was in afib as the reading was "scribble scratch, dark with black lines" (dbs device was not turned off) even though the doctor listened to the patient's chest and heard a regular heartbeat, and they went to the hospital.They turned off the dbs device off and performed an ekg and the doctor's at the hospital confirmed the patient was not in afib.The caller stated they had troubles both times with the first doctors not understanding them when they stated they needed to turn the dbs device off for accurate readings and inquired about getting documentation so that the issue wouldn't happen again.Patient services reviewed ekg/ecg and reviewed that doctors could call technical services (ts) or request information, and caller requested the information be sent to them to have.Ps sent ifp to patient per request based on situation and ps documented reported information.The caller mentioned when they had gone to turn off the dbs device yesterday for the ekg at the hospital, they saw eri (no allegations made related to battery longevity).Ps reviewed and the patient was redirected to their healthcare provider.Additional information received from the consumer reported when they operated to replace the device due to normal battery depletion they found a bent wire so they had to replace that too (the patient had fallen on it a few times over the years).Surgery took place on december 18th and 21st.

• Brand Name: ACTIVA
• Type of Device: STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINS
• 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: 16216658
• MDR Text Key: 307817131
• Report Number: 3004209178-2023-00898
• 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: Other
• Type of Report: Initial
• Report Date: 01/20/2023

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: 12/28/2019
• Device Model Number: 37601
• Device Catalogue Number: 37601
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 01/13/2023
• Initial Date FDA Received: 01/20/2023
• Date Device Manufactured: 07/02/2018
• 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 Outcome(s): Required Intervention
• Patient Age: 77 YR
• Patient Sex: Male