MAUDE Adverse Event Report: MEDTRONIC NEUROMODULATION ACTIVA; STIMULATOR, ELECTRICAL, IMPLANTED, FOR ESSENTI

Model Number 37612

Device Problem Insufficient Information (3190)

Patient Problems Shaking/Tremors (2515); Paresthesia (4421)

Event Date 03/21/2022

Event Type  Injury  

Manufacturer Narrative

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

Event Description

It was reported that patient (pt) is so tremulous, pt's newest ins on the right side has something wrong with it.Caller said ever since (b)(6) 2022 right after the surgery they knew something was wrong right away, because pt had side effects such as: tingling across their chest that went into their head and down into their left arm and pt has increased tremors whether the stimulators are turned on or off, the tremor is very severe, every bit of increased pain from other (unrelated) sources causes the tremor to be more severe.Caller said pt had a broken ankle that was recently pinned and repaired, the ankle pain caused increased tremors.Caller said pt has had xrays they have checked all the wires, they cannot find anything wrong.Caller said pt has been working with several doctors to resolve this.Pt will be going to hcp on (b)(6) for surgery to resolve it.

• Brand Name: ACTIVA
• Type of Device: STIMULATOR, ELECTRICAL, IMPLANTED, FOR ESSENTI
• Manufacturer (Section D): MEDTRONIC NEUROMODULATION; 7000 central ave ne; minneapolis MN 55432
• Manufacturer (Section G): MEDTRONIC NEUROMODULATION; 7000 central ave ne; minneapolis MN 55432
• Manufacturer Contact: glen belmer ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 6122713209
• MDR Report Key: 14518751
• MDR Text Key: 293264479
• Report Number: 2182207-2022-00899
• Device Sequence Number: 1
• Product Code: PJS
• UDI-Device Identifier: 00763000519247
• UDI-Public: 00763000519247
• 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: 05/26/2022

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: 11/28/2022
• Device Model Number: 37612
• Device Catalogue Number: 37612
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 05/23/2022
• Initial Date FDA Received: 05/26/2022
• Date Device Manufactured: 12/29/2021
• 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): Required Intervention
• Patient Age: 76 YR
• Patient Sex: Male