MAUDE Adverse Event Report: NEUROMED INC. NEUROSTIMULATION SYSTEM; STIMULATOR, SPINAL-CORD, IMPLANTED (PAIN RELIEF)

Model Number P1600B

Device Problems Material Protrusion/Extrusion (2979); Therapeutic or Diagnostic Output Failure (3023)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Type  Injury  

Event Description

The nurse reported that patient's neuromed device is sticking out of wound and out of patient's chest.Patient indicated to the nurse that the neuromed neurostimulation system isn't working.(b)(4).This report reflects information received by fda in the form of a notification per 803.22 (b)(2).

• Brand Name: NEUROSTIMULATION SYSTEM
• Type of Device: STIMULATOR, SPINAL-CORD, IMPLANTED (PAIN RELIEF)
• Manufacturer (Section D): NEUROMED INC.
• MDR Report Key: 17526378
• MDR Text Key: 321133947
• Report Number: MW5133317
• 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: Other
• Type of Report: Initial
• Report Date: 07/18/2012

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/12/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Model Number: P1600B
• Patient Sequence Number: 1