MAUDE Adverse Event Report: MEDTRONIC PUERTO RICO OPERATIONS CO. ACTIVA; IMPLANTED SUBCORTICAL ELECTRICAL STIMULATOR (M

Model Number 37612

Device Problems Failure to Deliver Energy (1211); Unintended Collision (1429); Inappropriate/Inadequate Shock/Stimulation (1574); Charging Problem (2892)

Patient Problems Pain (1994); Electric Shock (2554); Insufficient Information (4580)

Event Date 12/01/2021

Event Type  malfunction  

Event Description

It was reported that information was received from a patient's representative regarding an implantable neurostimulator (ins) and an external device.The caller was not with the equipment or the patient and stated the patient had dementia, was unable to follow directions, and neither the patient nor anyone else would be able to call ps to provide s/ns or further troubleshooting.The caller reported that the patient was in a severe car accident last december.They had gone to the neurologist and had the system checked; everything was fine, other than the wireless recharger (wr) needed to be reset due to connection issues.They reset the wr, and when they got home, they kept resetting the wr, but the wr was still not connecting right and would just continually beep, and the issue persisted.The caller said that sometime since the first doctor visit, the dbs device had shocked the patient (no harm reported), so they turned the dbs device off, and the patient went without it for a day or two.The caller stated the doctor had checked everything and reset everything, just that the wr was not connecting and would not charge the ins.There was not enough charge in the patient's ins, so the patient had been okay for a while, just that in the last couple of months, the patient was having neck fits and was in a lot of pain because of their dystonia which the dbs device was implanted for as the patient could not sufficiently charge the ins to address the symptoms.The caller added that the patient's drape had been worn out as they had it for a long time and mentioned something along the lines of the patient having it during the car accident as they would charge in the car and that over time the drape continued to wear out.The caller did not know the patient's size and requested a medium after review.The caller mentioned the charging cable for the dock had been lost and was unsure if the patient had disposed of it or what had happened.Still, they had gotten a replacement themselves (not through ps), and that the original wr cord adaptor they were not sure if that was what was being used or if a different adaptor was being used, and added that the wr didn't seem to be charging correctly from the dock, in that probably this month, the wr was not getting a full charge from the wr dock.The caller stated that they didn't think the cord or possibly a different adaptor were giving enough power and then mentioned that because of the patient's situation, they were under the impression the patient had caused damage to the dock by possibly sticking the cord the wrong way in as the patient would do a lot of things that wouldn't make sense.  the caller requested all external equipment for the recharger to be replaced and obtained a new drape for replacement as the patient was having a tough time.As they had seen the doctor many times throughout, they believed all equipment needed to be replaced to help resolve the patient's situation.Due to persistent caller requests for all parts replacements and statements that the caller would not be able to obtain s/n or get anyone to go through troubleshooting with ps, pss sent an e mail to repair to send replacements for wr, wr dock, wr cord, wr adaptor, and wr drape size m.Pss attempted to call the caller back for further clarification, to confirm the date of drape worn out and ask the date of the patient experiencing the shock, and left a vm to call ps back.

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.

• Brand Name: ACTIVA
• Type of Device: IMPLANTED SUBCORTICAL ELECTRICAL STIMULATOR (M
• 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: 16000365
• MDR Text Key: 308241874
• Report Number: 3004209178-2022-16567
• Device Sequence Number: 1
• Product Code: MRU
• UDI-Device Identifier: 00763000100360
• UDI-Public: 00763000100360
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: H020007
• 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: 12/16/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/16/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/28/2021
• Device Model Number: 37612
• Device Catalogue Number: 37612
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/07/2022
• Date Device Manufactured: 09/08/2020
• 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: 79 YR
• Patient Sex: Male