MAUDE Adverse Event Report: BOSTON SCIENTIFIC UNKNOWN; STIMULATOR, SPINAL-CORD, IMPLANTED (PAIN RELIEF)

Device Problem Insufficient Information (3190)

Patient Problems Bacterial Infection (1735); Purulent Discharge (1812)

Event Type  Injury  

Event Description

Patient reported having experienced a staph infection when they had their boston scientific scs device removed in (b)(6) 2013.Healthcare professional had removed two coffee cups of puss from the patient's back and the patient had been on home health for six weeks post-surgery.(b)(4).This report reflects information received by fda in the form of a notification per 803.22 (b)(2).

• Brand Name: UNKNOWN
• Type of Device: STIMULATOR, SPINAL-CORD, IMPLANTED (PAIN RELIEF)
• Manufacturer (Section D): BOSTON SCIENTIFIC
• MDR Report Key: 17525776
• MDR Text Key: 321082710
• Report Number: MW5132717
• 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: 03/13/2014

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
• Patient Sequence Number: 1