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

Device Problem Material Twisted/Bent (2981)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 03/28/2014

Event Type  Injury  

Manufacturer Narrative

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

Event Description

Device 1 of 2.Reference mfr report: 1627487-2014-26300.It was reported the pt underwent a surgical procedure to replace her ipg for an unrelated issue.During the procedure, it was identified the pns leads (off label) were tangled at the ipg site.The physician elected to explant the pns leads and lead extensions.It was noted the leads were not replaced; however, effective stimulation was achieved using the existing tripole lead.

• Brand Name: UNKNOWN
• Type of Device: SCS LEAD
• Manufacturer (Section D): ST. JUDE MEDICAL - NEUROMODULATION; plano TX
• Manufacturer Contact: tanja hoffman ; 6901 preston road; plano, TX 75024 ; 9723098520
• MDR Report Key: 3782873
• MDR Text Key: 19397548
• Report Number: 1627487-2014-26328
• Device Sequence Number: 1
• Product Code: GZB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P010032
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Not Applicable
• Type of Report: Initial
• Report Date: 03/28/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/17/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/28/2014
• 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
• Treatment: IMPLANT DATE:; SCS IPG: MODEL: 3716; SCS LEAD: MODEL: 3219; IMPLANT DATE:
• Patient Outcome(s): Other
• Patient Age: 36 YR