MAUDE Adverse Event Report: KATALYST INTERACTIVE INC. KATALYST TRAINING SYSTEM; Stimulator, muscle, powered, for muscle conditioning

Model Number 1064-01-A04

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Unspecified Musculoskeletal problem (4535)

Event Date 08/23/2022

Event Type  Injury  

Event Description

Member reported getting rhabdomyolysis after using katalyst and following up with a hiit session the next day.Member is also on adhd meds of concerta.

Manufacturer Narrative

Evaluation: vest, shorts, arm straps: used dmm to measure resistance on all pads and to check for any cross connections.No issues found.Behavior as expected per specifications impulse pack: connected the ip to load board and went through the app pre workout check to see all channel connections.All channels work as expected to specifications measured all impulse parameters (current, pulse width and frequency) using oscilloscope for all channels.No issues found.Behavior as expected to specifications.

• Brand Name: KATALYST TRAINING SYSTEM
• Type of Device: Stimulator, muscle, powered, for muscle conditioning
• Manufacturer (Section D): KATALYST INTERACTIVE INC.; 8400 west sunset road #300; las vegas NV 89113
• Manufacturer (Section G): KATALYST INTERACTIVE; 8400 west sunset road #300; las vegas NV 89113
• Manufacturer Contact: claudia maldonado ; 8400 west sunset road #300; las vegas, NV 89113
• MDR Report Key: 19008420
• MDR Text Key: 338980755
• Report Number: 3014545203-2024-00001
• Device Sequence Number: 1
• Product Code: NGX
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K190966
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Other
• Remedial Action: Replace
• Type of Report: Initial
• Report Date: 03/29/2024

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?: No
• Device Operator: Lay User/Patient
• Device Model Number: 1064-01-A04
• Device Lot Number: 1053-3
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 08/16/2022
• Initial Date FDA Received: 03/29/2024
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Treatment: SKU 1065-01-A04 LOT 1053-3; SKU 1066-01-A04 LOT 1053-4; SKU 1156-01-D00 LOT 166550
• Patient Outcome(s): Other
• Patient Sex: Male