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

Model Number 3186

Device Problems Therapy Delivered to Incorrect Body Area (1508); Inappropriate/Inadequate Shock/Stimulation (1574)

Patient Problems Discomfort (2330); Inadequate Pain Relief (2388); Shock from Patient Lead(s) (3162)

Event Date 12/01/2009

Event Type  Injury  

Event Description

Device 2 of 2.Reference mfr report# 1627487-2014-12547.Note: the pt received two model 3166 leads from the same lot.It was reported the pt experienced shocking at the lead site.In (b)(6) 2009 the octrode lead was curled.The physician straightened and repositioned the lead.Following the lead revision, the pt did not regain effective stimulation and received unintended stimulation in his ribs.The pt also was still experiencing shocking in his right side as well.The pt stopped using and recharging the system in 2010.The pt wants the system explanted.

Manufacturer Narrative

Sjm has limited info 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: QUATTRODE
• Type of Device: SCS LEAD
• Manufacturer (Section D): ST. JUDE MEDICAL - NEUROMODULATION; plano TX
• Manufacturer Contact: connie timmons ; 6901 preston rd.; plano, TX 75024 ; 9723098054
• MDR Report Key: 4059713
• MDR Text Key: 4808957
• Report Number: 1627487-2014-12548
• Device Sequence Number: 1
• Product Code: GZB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K072462
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Not Applicable
• Type of Report: Initial
• Report Date: 07/15/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 08/01/2011
• Device Model Number: 3186
• Device Lot Number: 2838231
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 07/15/2014
• Initial Date FDA Received: 08/08/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/01/2009
• 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; SCS EXTENSION: MODEL 3342; IMPLANT DATE:; IMPLANT DATE:
• Patient Outcome(s): Other
• Patient Age: 33 YR