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

Model Number 3183

Device Problems Migration or Expulsion of Device (1395); Pocket Stimulation (1463)

Patient Problems Discomfort (2330); Inadequate Pain Relief (2388)

Event Date 12/19/2013

Event Type  Injury  

Event Description

The patient ((b)(6)) is implanted with two percutaneous leads from the same lot.It was reported the patient's stimulation has suddenly become too strong.Upon further interrogation, it was found that one of the two leads produced a tingling sensation in the ipg pocket site.An x-ray revealed lead migration.Surgical intervention will be undertaken at a later date to address this issue.New programming was issued for the patient's use until such time.

Manufacturer Narrative

Sjm 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.Sjm defers to the patient's physician regarding medical history.

• Brand Name: OCTRODE
• Manufacturer (Section D): ST. JUDE MEDICAL - NEUROMODULATION; plano TX
• Manufacturer Contact: courtney weddington ; 6901 preston rd.; plano, TX 75024 ; 9725264859
• MDR Report Key: 3682923
• MDR Text Key: 4260401
• Report Number: 1627487-2014-00024
• Device Sequence Number: 1
• Product Code: GZB
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: P010032
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Not Applicable
• Type of Report: Initial
• Report Date: 12/19/2013

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/10/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 07/01/2015
• Device Model Number: 3183
• Device Lot Number: 4175366
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/19/2013
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/01/2013
• 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
• Treatment: SCS IPG: MODEL 3788
• Patient Outcome(s): Other