MAUDE Adverse Event Report: ST. JUDE MEDICAL; STIMULATOR, SPINAL-CORD, IMPLANTED

Model Number 3788

Device Problem Insufficient Information (3190)

Patient Problems Pain (1994); Therapeutic Response, Decreased (2271)

Event Date 05/19/2014

Event Type  malfunction  

Event Description

Patient had a spinal cord stimulator placed for chronic pain.Patient complained of loss of stimulation in the painful area about 40 minutes after the procedure and was unable to get any stimulation over the last 2 or 3 days.He went to see the doctor four days later.It was determined that the spinal cord stimulator lead was not connected to the ipg generator.He went back to surgery to have the spinal cord stimulator removed and replaced.

• Type of Device: STIMULATOR, SPINAL-CORD, IMPLANTED
• Manufacturer (Section D): ST. JUDE MEDICAL; one st. jude medical drive; st paul MN 55117
• MDR Report Key: 3868220
• MDR Text Key: 4507057
• Report Number: 3868220
• Device Sequence Number: 1
• Product Code: GZB
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 05/22/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/22/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Invalid Data
• Device Model Number: 3788
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 05/22/2014
• Event Location: Home
• Date Report to Manufacturer: 06/12/2014
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 39 YR