MAUDE Adverse Event Report: MEDTRONIC MED REL MEDTRONIC PUERTO RICO ACTIVA; STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINS

Model Number 37612

Device Problems Unintended Collision (1429); Inappropriate/Inadequate Shock/Stimulation (1574); Electromagnetic Compatibility Problem (2927)

Patient Problem Electric Shock (2554)

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported that  in the last few weeks, the patient has been experiencing electrical sensations, or "zaps" internally when near certain electronics occasionally.For example, caller mentioned the patient felt a zap when they brushed their arm on a lamp the other night, as well as last night, the caller plugged in their charging cable adaptor into the wall, and then when attempting to plug in the charger into the iphone, the patient who was about 3 1/2 feet away, felt a sensation, squealed, and made physical movements that indicated stop.The caller stated that when they plugged the cable into the iphone before plugging the adaptor into the wall, the patient did not feel a sensation.Patient services (pss) asked caller if anything out of the ordinary has happened in the past few weeks.The caller stated not recently, but that sometime in the last several months, the patient fell and bumped their head pretty hard and hit one part of their implantable system.Caller mentioned that the patient did not have any reaction or symptoms exhibited after the fall, just within the last few weeks.The caller mentioned that the patient has parkinson's, and stated they were not aware if the patient's falls were related to their dbs device.The patient was redirected to their healthcare provider to further address the issue.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 was received from the healthcare provider (hcp) who reported that the cause of the shocking was that the patient hit their head and it had nothing to do with the stimulator.It was reported that the fall was not related to their dbs device or therapy.Actions taken was the patient was examined, scan done, and device check.The issue was resolved.

• Brand Name: ACTIVA
• Type of Device: STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINS
• Manufacturer (Section D): MEDTRONIC MED REL MEDTRONIC PUERTO RICO; road 31, km. 24, hm 4; ceiba norte industrial park; juncos PR 00777
• Manufacturer (Section G): MEDTRONIC MED REL MEDTRONIC PUERTO RICO; 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: 14517254
• MDR Text Key: 293084062
• Report Number: 3004209178-2022-06823
• Device Sequence Number: 1
• Product Code: MHY
• 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: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 08/09/2022

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: 03/14/2011
• Device Model Number: 37612
• Device Catalogue Number: 37612
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 05/25/2022
• Initial Date FDA Received: 05/26/2022
• Supplement Dates Manufacturer Received: 08/05/2022
• Supplement Dates FDA Received: 08/10/2022
• Date Device Manufactured: 04/22/2010
• 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: 75 YR
• Patient Sex: Female
• Patient Weight: 66 KG