MAUDE Adverse Event Report: NALU MEDICAL IPG UNIT; STIMULATOR, SPINAL-CORD, IMPLANTED (PAIN RELIEF)

Patient Problem Failure of Implant (1924)

Event Date 11/30/2023

Event Type  malfunction  

Event Description

Patient schedule for a scs ((spinal cord stimulator)) ipg (implanted pulse generator) revision d/t potential of a lead not working.During procedure ipg (implanted pulse generator) unit sn (serial number): (b)(6) and ipg (implanted pulse generator) lead was interrogated by nalu rep, and it was determined that the ipg (implanted pulse generator) unit was the malfunctioning part of the scs (spinal cord stimulator) unit.New ipg (implanted pulse generator) unit was swapped and was tested and verified connection.

• Brand Name: IPG UNIT
• Type of Device: STIMULATOR, SPINAL-CORD, IMPLANTED (PAIN RELIEF)
• Manufacturer (Section D): NALU MEDICAL
• MDR Report Key: 18518036
• MDR Text Key: 333024008
• Report Number: MW5150207
• Device Sequence Number: 1
• Product Code: GZB
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 01/09/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/12/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Patient Sequence Number: 1
• Treatment: NALU IPG LEAD.
• Patient Age: 76 YR
• Patient Sex: Female
• Patient Weight: 101 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White