MAUDE Adverse Event Report: ST. JUDE MEDICAL - NEUROMODULATION; SCS LEAD

Device Problems Material Fragmentation (1261); High impedance (1291)

Patient Problem Inadequate Pain Relief (2388)

Event Date 06/22/2018

Event Type  Injury  

Manufacturer Narrative

The manufacturer has limited information related to the patient's medical history and is unable to form an opinion as to the relevancy of the patient's history to the event reported.The manufacturer defers to the patient's physician regarding medical history.

Event Description

It was reported ((b)(6)) the patient was unable to experience any stimulation due to high impedances found on the lead.The physician elected to explant the affected lead, and 3 contacts on the lead came loose and remained inside the patient in the epidural space.The physician was able to remove the contacts from the patient during the same surgery.The physician then implanted a new lead, resolving the impedance issue.Device information is unknown at this time.

Event Description

Follow up information identified the patient¿s high impedance issue resolved with replacement of the lead.

• Type of Device: SCS LEAD
• Manufacturer (Section D): ST. JUDE MEDICAL - NEUROMODULATION; 6901 preston rd; plano TX 75024
• Manufacturer (Section G): ST. JUDE MEDICAL - NEUROMODULATION; 6901 preston rd; plano TX 75024
• Manufacturer Contact: joanne story ; 9725264875
• MDR Report Key: 7717689
• MDR Text Key: 114942302
• Report Number: 1627487-2018-06816
• Device Sequence Number: 1
• Product Code: GZB
• Combination Product (y/n): N
• Reporter Country Code: BE
• PMA/PMN Number: P010032
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 09/18/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 06/28/2018
• Initial Date FDA Received: 07/25/2018
• Supplement Dates Manufacturer Received: 08/28/2018
• Supplement Dates FDA Received: 09/18/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other