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

Model Number 3186

Device Problems Migration or Expulsion of Device (1395); Failure to Advance (2524); Device Operates Differently Than Expected (2913)

Patient Problem Inadequate Pain Relief (2388)

Event Date 03/20/2014

Event Type  Injury  

Event Description

It was reported both of the pt's leads (from the same lot) migrated following being implanted.In turn, the pt has been receiving inadequate coverage.As a result, the pt underwent surgical intervention on (b)(6) 2014.During the procedure, the doctor was able to reposition one of the leads.The other lead was left where it had migrated due to it being unable to be repositioned.Add'l anchors were also implanted during the procedure.Post-op, effective coverage was still unattainable.As a result, the pt will see a neurosurgeon for another attempt at surgical intervention.

Manufacturer Narrative

Sjm has limited info 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.

• Brand Name: OCTRODE
• Type of Device: SCS LEAD
• Manufacturer (Section D): ST. JUDE MEDICAL - NEUROMODULATION; plano TX
• Manufacturer Contact: ahmad johnson ; 6901 preston rd.; plano, TX 75024 ; 9725264667
• MDR Report Key: 3820996
• MDR Text Key: 19486966
• Report Number: 1627487-2014-05329
• 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: 04/17/2014

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?: No
• Device Operator: Health Professional
• Device Expiration Date: 01/01/2016
• Device Model Number: 3186
• Device Lot Number: 4432412
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 04/17/2014
• Initial Date FDA Received: 05/08/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/01/2014
• 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:; IMPLANT:; SCS IPG: MODEL 3788; SCS ANCHORS: MODEL 1192 (X2)
• Patient Outcome(s): Other
• Patient Age: 45 YR