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

Model Number 3186

Device Problems Migration or Expulsion of Device (1395); Device Operates Differently Than Expected (2913)

Patient Problems Purulent Discharge (1812); Inadequate Pain Relief (2388); Post Operative Wound Infection (2446)

Event Date 06/26/2014

Event Type  Injury  

Event Description

Device 1 of 3.Ref mfr reports: 1627487-2014-01473, 01474.It was reported the pt is without left side stimulation.The pain pattern is bilateral back and legs.After further investigation, it was revealed the lead has migrated from t8 to t11.No known traumatic events have occurred.Surgical intervention was undertaken on (b)(6) 2014 in efforts to revise the leads.During procedure, the physician noted purulent drainage and puss extending from the lead and ipg sites.Subsequently, the physician opted to explant the scs system.Culture were taken, however, results are unk at this time.

Manufacturer Narrative

Method: the device history and sterilization records were reviewed.Results: the device history and sterilization records reviewed were found to meet specifications and no anomalies related to this event were found.Conclusion: the cause of the reported complaint could not be determined from the review of the dhr and sterilization records.Sjm has limited info 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.Sjm defers to the patient's physician regarding medical history.

• Brand Name: OCTRODE
• Type of Device: SCS LEAD
• Manufacturer (Section D): ST. JUDE MEDICAL - NEUROMODULATION; plano TX
• Manufacturer Contact: melissa nkematu ; 6901 preston rd.; plano, TX 75024 ; 9723092520
• MDR Report Key: 3960642
• MDR Text Key: 4562522
• Report Number: 1627487-2014-01472
• 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: 06/26/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/21/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 11/01/2015
• Device Model Number: 3186
• Device Lot Number: 4358121
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/26/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/01/2013
• 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
• Patient Age: 86 YR