MAUDE Adverse Event Report: MEDTRONIC MED REL MEDTRONIC PUERTO RICO ACTIVA; IMPLANTED SUBCORTICAL ELECTRICAL STIMULATOR (M

Model Number 37612

Device Problems Failure to Deliver Energy (1211); No Device Output (1435); Charging Problem (2892)

Patient Problems Dysphasia (2195); Shaking/Tremors (2515); Convulsion/Seizure (4406); Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 04/18/2022

Event Type  Injury  

Manufacturer Narrative

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

Event Description

It was reported that about a week ago, the patient noticed that the desktop charger (dtc) cord was damaged.At the same time, they noticed that the recharger display would turn off after about 15 minutes while charging their ins, when it normally would stay on for 30-45 minutes before turning off.During the call, the patient started charging their ins.Initially, none of the coupling bars were filled in, but the patient confirmed they were able to get all 8 coupling bars filled in after repositioning the antenna.Shortly thereafter, the patient saw the 'neurostimulator charge sufficient' screen.Agent reviewed the meaning of the screen.Agent asked the patient to report what they were seeing in the status row, and they noted that therapy was turned off.The patient stated that they have therapy turned on 24/7, so they did not know how therapy turned off.Agent reviewed that therapy could turn off if the ins battery level got too low.At the time of the call, the patient's ins was 3/4 charged.The patient was unable to turn therapy on during the call because the patient programmer batteries were depleted, and they did not have aaa batteries on hand.The patient has the 37642 patient programmer manual, and said they would look through it to learn how to therapy back on once they have aaa batteries in the programmer, and said they would call patient services if they needed further assistance.No allegations were made regarding therapy.An email was sent to repair to replace the dtc.Additional information was received from a patient's representative that patient (pt) was having a hard time communicating.Caller said they "just got done replacing the battery to check the charge" when pt's symptoms returned.Caller reported they think pt's stimulator was accidentally shut off when pt used the control device about 10-15 minutes ago the patient's really bad convulsion symptoms returned, like before getting the ins, caller said it set the patient off badly.Caller said the convulsions took 30-45 seconds and pt told them they think they "overcharged" it.Pt said "the charger got turned off" they "tried to turn it back on" patient services (pss) worked with callers to use the programmer to check.Pt used the controller and confirmed seeing on/ok, the ins battery icon showed the ins battery was 100 percent charged.Caller said as soon as pt used it they think it turned stim back on, caller said pt was getting her color in their face.Pt said they were still feeling shaky.Reviewed stim off can cause medical symptoms and recommended they let their doctor know this happened.The troubleshooting steps that were taken on the call resolved the issue.Pt reports they would inform their hcp.

• Brand Name: ACTIVA
• Type of Device: IMPLANTED SUBCORTICAL ELECTRICAL STIMULATOR (M
• 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: 14272926
• MDR Text Key: 290790022
• Report Number: 3004209178-2022-05555
• Device Sequence Number: 1
• Product Code: MRU
• 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: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 05/02/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/04/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/14/2011
• Device Model Number: 37612
• Device Catalogue Number: 37612
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/28/2022
• Date Device Manufactured: 12/20/2010
• 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 Outcome(s): Other
• Patient Age: 81 YR
• Patient Sex: Female