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

Model Number 37601

Device Problem Loss of Data (2903)

Patient Problems Dyspnea (1816); Dyskinesia (2363); Insufficient Information (4580)

Event Date 01/06/2022

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported that manufacturer representative (rep) was trying to setup patient's handset today, but when she connected there is no programming.Tablet showed battery information but no programming.Report didn't show any programming either.Rep said patient met with hcp and since that day patient has been feeling "funny".Rep said patient has dyskinesia, different "mood", that patient is more talkative because patient can breath better.Prior to last thursday, patient gasps for air.Technical services (ts) reviewed with rep that hcp might have wiped patient's programming last thursday, otherwise the report would have patient's programming.Rep to seek previous reports from hcp to reprogram patient. the issue was not resolved.

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

Additional information received from the manufacturer¿s representative (rep), which was confirmed with the healthcare provider (hcp), reported the patient¿s biggest complaint was having dyskinesia and mood changes (feeling funny).The cause of the no programming and patient symptoms wasn¿t determined, but it was believed to be the hcp may have wiped out the patient¿s programming by mistake.The patient was reprogrammed with therapy prescribed by their hcp and education was performed on how to work the new handset.Following this the issue was resolved and symptoms were resolved.

• 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: 13251598
• MDR Text Key: 283764677
• Report Number: 3004209178-2022-00587
• 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: Health Professional,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 01/19/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/13/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/28/2020
• Device Model Number: 37601
• Device Catalogue Number: 37601
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/14/2022
• Date Device Manufactured: 10/12/2018
• 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 Age: 58 YR
• Patient Sex: Female