MAUDE Adverse Event Report: STIMWAVE TECHNOLOGIES INCORPORATED STIMWAVE FREEDOM STIMULATORS; STIMULATOR, SPINAL-CORD, IMPLANTED (PAIN RELIEF)

Device Problems Failure to Charge (1085); Therapeutic or Diagnostic Output Failure (3023)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 02/11/2020

Event Type  malfunction  

Event Description

Stimwave battery doesn't hold a charge, supposed to last 12 hours.The stim/wave wearable pad stopped working, carries stimulate to nerves via implanted stimwave implants.Fda safety report id# (b)(4).

• Brand Name: STIMWAVE FREEDOM STIMULATORS
• Type of Device: STIMULATOR, SPINAL-CORD, IMPLANTED (PAIN RELIEF)
• Manufacturer (Section D): STIMWAVE TECHNOLOGIES INCORPORATED
• MDR Report Key: 9823644
• MDR Text Key: 183352283
• Report Number: MW5093691
• Device Sequence Number: 1
• Product Code: GZB
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 03/09/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/11/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Was Device Available for Evaluation?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 76 YR
• Patient Weight: 72