MAUDE Adverse Event Report: ST. JUDE MEDICAL STIMULATOR, SPINAL-CORD, IMPLANTED (PAIN RELIEF)

Device Problem Insufficient Information (3190)

Patient Problem Insufficient Information (4580)

Event Type  malfunction  

Event Description

Boston scientific neuromodulation (bsn) received information about an event that would have been reportable under 21 cfr 803, medical device reporting within our complaint system.However, the issue reported was related to an implanted spinal cord stimulator manufactured by st.Jude medical-ans.A complaint was received on (b)(6) 2009 that an ans patient was scheduled to undergo an ipg revision procedure for an unknown reason.The explanted ans ipg was not returned to bsn.This report reflects information received by fda in the form of a notification per 803.22 (b)(2).

• Brand Name: STIMULATOR, SPINAL-CORD, IMPLANTED (PAIN RELIEF)
• Type of Device: STIMULATOR, SPINAL-CORD, IMPLANTED (PAIN RELIEF)
• Manufacturer (Section D): ST. JUDE MEDICAL
• MDR Report Key: 17526917
• MDR Text Key: 321354544
• Report Number: MW5133854
• 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: 03/18/2010

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