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); Impedance Problem (2950)

Patient Problems Device Overstimulation of Tissue (1991); Inadequate Pain Relief (2388); Shock from Patient Lead(s) (3162)

Event Date 05/19/2014

Event Type  Injury  

Event Description

Device 1 of 2.Ref mfr report: 1627487-2014-26857.It was reported the pt is experiencing overstimulation in the groin area; however, is not receiving stimulation on the left side.Lead diagnostics revealed multiple low impedances.Reprogramming was initially able to resolve the issue.Follow up info identified the pt continued to experience overstimulation and ineffective stimulation.An x-ray was taken and confirmed one of the leads had migrated.The pt underwent surgical intervention to remove and replace the leads.The pt is now receiving effective stimulation.

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
• Type of Device: SCS LEAD
• Manufacturer (Section D): ST. JUDE MEDICAL - NEUROMODULATION; plano TX
• Manufacturer Contact: tanja hoffman ; 6901 preston rd.; plano, TX 75024 ; 9723098520
• MDR Report Key: 4202015
• MDR Text Key: 15363858
• Report Number: 1627487-2014-26851
• 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: 09/25/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/17/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/01/2015
• Device Model Number: 3186
• Device Lot Number: 4292301
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 09/25/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/01/2013
• 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 ANCHOR, MODEL 1192 (2),; SCS IPG, MODEL 3788,; IMPLANT DATE:; IMPLANT DATE:
• Patient Outcome(s): Other
• Patient Age: 62 YR