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

Model Number 3186

Device Problems Migration or Expulsion of Device (1395); Therapy Delivered to Incorrect Body Area (1508); Difficult to Advance (2920)

Patient Problems Therapeutic Effects, Unexpected (2099); Discomfort (2330)

Event Date 05/28/2014

Event Type  Injury  

Event Description

Device #2 of 2.Reference mfr report: 1627487-2014-26512.The patient had a scs system which includes two leads from the same lot.It was reported the patient was experiencing discomfort where the side of the ipg was irritating her.The patient reported that she was receiving effective stimulation.The patient underwent a revision procedure on (b)(6) 2014 and imaging in the operating room indicated the right lead had migrated.The physician inserted a stylet into the right lead but had difficulty advancing the lead to the desired location.The lead was tested intraoperatively and the patient experienced rib stimulation.The physician then explanted the entire scs system.The physician is going to allow the patient to recover from this surgical procedure before further intervention is taken.

Manufacturer Narrative

Sjm has limited information related to the patient's medical history an 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: 4195914
• MDR Text Key: 5151396
• Report Number: 1627487-2014-26513
• 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: 05/28/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/17/2014
• 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: 05/28/2014
• 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: 80 YR