MAUDE Adverse Event Report: MEDTRONIC PUERTO RICO OPERATIONS CO. ACTIVA; Stimulator, electrical, implanted, for parkinsonian tremor

Model Number 37612

Device Problems Electromagnetic Interference (1194); Failure to Deliver Energy (1211)

Patient Problem Insufficient Information (4580)

Event Date 11/01/2022

Event Type  Injury  

Event Description

It was reported that the manufacturer representative (rep) states patient is calling to see if there is a problem with the programmer.Patient states having a mri the middle of november and settings were put on group b for themri and patient thinks it turned ins off.Rep states sometimes patients can be set up with a group for mri.Patient states going back to group a.Rep thinks patient may have accidently turned ins off himself but is not sure.Patient states having a problem last week (no other info was given) about 8 weeks later, body shut down and patient states being put back on group b by neurologist to have another mri and the ins was off.Patient states deteriorate and suffering and thinks ins had been off for a couple months.Patient thinks battery is operating fine and it is the programmer that is the issue.Patient states saturday the neurologist turned ins on patient did not have programmer with him and will call back.(b)(6)2023 rtg0397827 update (con): additional information was received from the patient stating they had been in the hospital and was related to their dbs device as they had the mri in november, and think the implantable neurostimulator (ins) may have been left on b for the mri as they had been slowly digressing from thanksgiving to last week.Patient thinks they may have accidentally shut the ins off or the patient programmer (pp) had failed, or a combination of both as something like that did set them off, and when they had the ins off for 2 days (saturday and sunday this past week waiting for the mri), they felt really bad, so they really weren't sure what had happened or the cause prior.Caller's healthcare provider (hcp) said the patient looked fantastic now compared to last week and they were currently at the rehabilitation center.The caller was following up on whether they needed to be with the equipment to further address any potential issue with the pp.Patient services (pss) reviewed and caller stated their wife was bringing the pp and they would call back.Patient called back and pss walked them through using the pp and pp was working as intended.Caller mentioned they were on group a with 3.50 settings and confirmed therapy was on.Pp was in icon mode, and pss walked caller through changing to text mode.Caller stated because they learned the pp was working as intended, they believe what had happened was they thought they had switched the group from b to a, but must not have as making the change was very confusing for them due to the pp being cryptic and confusing to use.Therefore, for the last few weeks, they were likely on b and that's why the patient's functionality kept declining, and it was on saturday that the provider saw the patient was already on group b, and the patient had to wait on b waiting for permission for mri which was why they had a really bad time then, and once their group was turned back to a, they continued to get better.Caller provided feedback about the pp in that the device was very cryptic and was easy to read wrong and inquired about if there was a less cryptic device they could get.Pss reviewed the handset/communicator and redirected patient to hcp to further discuss.Manual for patient's current pp was sent.

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

• 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
• 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: 16266085
• MDR Text Key: 308404475
• Report Number: 3004209178-2023-01297
• Device Sequence Number: 1
• Product Code: MHY
• UDI-Device Identifier: 00643169864238
• UDI-Public: 00643169864238
• 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,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 01/30/2023

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: 07/28/2019
• Device Model Number: 37612
• Device Catalogue Number: 37612
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 01/25/2023
• Initial Date FDA Received: 01/30/2023
• Date Device Manufactured: 09/13/2018
• 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): Hospitalization
• Patient Age: 64 YR
• Patient Sex: Male