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

Model Number 3189

Device Problem Device Operates Differently Than Expected (2913)

Patient Problems Itching Sensation (1943); Burning Sensation (2146)

Event Date 08/24/2014

Event Type  Injury  

Event Description

Device 2 of 2.Reference mfr report #: 1627487-2014-20401.The pt has two peripheral (off-label) leads.It is unk which one is related to the issue.Therefore, both are being reported.It was reported the pt was experiencing burning and itching sensation with stimulation at the lead site of her peripheral sys.Surgical intervention may be taken at a later date to address the issue.

Manufacturer Narrative

Udi (di): (b)(4).Sjm has limited information 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 MED - NEUROMODULATION; plano TX
• Manufacturer Contact: taruna sharma ; 6901 preston rd.; plano, TX 75024 ; 9725269635
• MDR Report Key: 4252641
• MDR Text Key: 5016047
• Report Number: 1627487-2014-20402
• 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: 10/15/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/05/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 09/01/2014
• Device Model Number: 3189
• Device Lot Number: 3813908
• Other Device ID Number: 05414734401715
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/15/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/01/2012
• 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 DATE:; SCS IPG, MODEL 3788; SCS ANCHOR, MODEL 1192 (2); IMPLANT DATE:
• Patient Outcome(s): Other
• Patient Age: 59 YR