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

Model Number 37603

Device Problems Unintended Collision (1429); Unable to Obtain Readings (1516); Battery Problem (2885); Therapeutic or Diagnostic Output Failure (3023)

Patient Problems Fall (1848); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/23/2022

Event Type  malfunction  

Event Description

It was reported that patient that observed an oor on her right side activa sc.The oor occurred today when patient was back home after an ins replacement on her left ins (replaced today due to normal battery depletion.) the right side ins was checked prior to the patient leaving the hospital with no oor's observed.The patient is programmed in constant voltage, 3.8v w/ an upper limit of 4v.No interleaving, 1038 ohms for the impedance measurement, (3.7ma) manufacturer representative (rep) and patient services (pss) discussed impedance as possible cause - and pss sent email to caller reviewing a possible intermittent short circuit causing the issue.The caller wanted to confirm the ins was on, pss reviewed decreasing amplitude, confirming ins is on and then increase amplitude again.Rep called back and said the patient (pt) had a fall today, and the oor started after the fall.Rep said she has not checked impedances since the fall.Technical services (ts) reviewed that a short from the fall could cause oor.Rep had to end the call because t he pt was calling her on the other line.The issue was not resolved.Additional information received from the manufacturer¿s representative (rep), which was confirmed with the healthcare provider (hcp), reported impedances were checked following the fall with all impedances within normal range, but therapy impedance couldn¿t be measured as they got ¿---¿ in the spot where it would be listed.It was unknown if there was a short circuit when the patient fell.The patient was still receiving therapy but when stimulation was turned down their symptoms returned.The cause of the fall wasn¿t determined but wasn¿t believed to be related to the dbs device, and it was unknown what caused the oor message.The patient was instructed how to clear the oor with the neurostimulator being at 2.9v on february 23rd and was at 2.84 on february 25th.The battery depletion was quicker than normal and would be watched and replaced when it came closer to 2.6 v/eri.The patient was going to be continued to be monitored.

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
• 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: 13636829
• MDR Text Key: 295345944
• Report Number: 3004209178-2022-02656
• Device Sequence Number: 1
• Product Code: MHY
• UDI-Device Identifier: 00763000100353
• UDI-Public: 00763000100353
• 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: Health Professional,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 03/01/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/01/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/14/2021
• Device Model Number: 37603
• Device Catalogue Number: 37603
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/25/2022
• Date Device Manufactured: 12/20/2019
• 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: 74 YR
• Patient Sex: Female