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

Model Number 37612

Device Problems Failure to Deliver Energy (1211); Unintended Collision (1429)

Patient Problems Stroke/CVA (1770); Fall (1848); Pain (1994); Dysphasia (2195); Discomfort (2330); Cramp(s) /Muscle Spasm(s) (4521); Insufficient Information (4580)

Event Type  malfunction  

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

It was reported that, last year, the patient had a bad fall and believed they hit the ins and the ins had turned off.Caller stated they had worked with healthcare provider (hcp) and realized it was probably from the fall that the therapy had turned off.Caller stated the patient probably falls a dozen times a day, sometimes hard falls, and when asked when the patient began falling routinely, caller stated they really did not know but that the patient had a really rough probably 6 or 7 months and after thinking about it, could have been due to the fall last year but they were not sure.Caller stated since monday, the patient was having some symptoms they thought would go away but today the patient's legs had been hurting them, they hadn't been able to speak, and their entire demeanor changed, and they had believed the patient was having a stroke as nothing was working so the patient was currently in the er.Caller inquired about checking ins status as they believed a recent fall could have caused the patient's therapy to turn off.Therapy was turned off with ins battery ok.Caller mentioned that therapy turning off, they did not believe was due to battery depletion, but potentially a fall, as they stated the patient was very diligent with charging in which they would charge 5 or 6 hours a day sometimes as they believed the patient had high settings and ins was used all of the time, thus the ins needed to be charged more often.Agent reviewed turning therapy on was a medical decision and caller requested help turning therapy back on.Caller turned patient's therapy back on, and caller stated the patient's face was contorted, and they were having discomfort in their face.Over time, the patient was calming down and their face was becoming less contorted, their mouth was relaxing, and the patient was able to move th eir mouth, was swallowing, able to speak, and symptoms and discomfort were slowly resolving, so therapy having been turned on was helping immensely.By the end of the call, the caller stated the patient's demeanor had changed to where they were relaxed and their face was back to normal, and caller was extremely happy to see the patient doing much better after adjusting to therapy being back on.The caller was redirected to hcp to further address the issue.

• 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: 16461303
• MDR Text Key: 310444581
• Report Number: 3004209178-2023-02824
• Device Sequence Number: 1
• Product Code: MHY
• UDI-Device Identifier: 00643169529762
• UDI-Public: 00643169529762
• 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: 03/01/2023

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: 08/28/2016
• Device Model Number: 37612
• Device Catalogue Number: 37612
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 02/22/2023
• Initial Date FDA Received: 03/01/2023
• Date Device Manufactured: 10/12/2015
• 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 Sex: Male