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

Model Number 37603

Device Problems Inappropriate/Inadequate Shock/Stimulation (1574); Battery Problem (2885)

Patient Problems Bruise/Contusion (1754); Numbness (2415); 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 june of last year, their son hit them in the chest "right over" the location of the left ins battery, and the area turned black and blue.About a week ago, the patient felt that therapy was "not near as strong" as it used to be.However, the patient also stated that the therapy still seemed to work for their essential tremor.Yesterday, the patient was checking the left ins battery with the patient programmer and noticed a 'contact clinician' message with eri.The patient also checked the right ins battery, but they did not see eri.The patient called today to find out what eri meant.During the call, the patient checked the left ins and saw the eri message screen.Agent reviewed how to bypass the screen, and the patient confirmed that therapy was on.Agent did not have the patient check the right ins because they stated that they had checked it prior to calling, noting that it was working perfectly.Agent reviewed meaning of eri, and the patient was upset to hear that it meant the left ins battery level was low and would require replacement soon.The patient stated that the last time they had the left ins battery checked (they have it checked every 6 months), they were told that it would last 10 years.The patient stated that they had already made an appointment to see their managing healthcare provider/neurologist next week.The patient was redirected to their healthcare provider to further address the issue.The patient's relevant medical history included that they feel a momentary " little zap" and numbness in their jaw/cheek when they turn therapy on (the patient stated that they turn therapy off every night, and turn it back on in the morning), which then goes away.The patient stated that they have felt those sensations ever since implant date.

• Brand Name: ACTIVA
• Type of Device: STIMULATOR, ELECTRICAL, IMPLANTED, FOR ESSENTI
• 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: 14193801
• MDR Text Key: 290197291
• Report Number: 3004209178-2022-05197
• Device Sequence Number: 1
• Product Code: PJS
• UDI-Device Identifier: 00613994761071
• UDI-Public: 00613994761071
• 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
• Report Date: 04/25/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/25/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/28/2016
• Device Model Number: 37603
• Device Catalogue Number: 37603
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/21/2022
• Date Device Manufactured: 12/12/2014
• 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: 71 YR
• Patient Sex: Male