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

Model Number 3146

Device Problems High impedance (1291); Kinked (1339); Device Operates Differently Than Expected (2913)

Patient Problem Inadequate Pain Relief (2388)

Event Date 01/23/2014

Event Type  Injury  

Event Description

Device 2 of 2.Reference mfr report #: 1627487-2014-25117.It was reported the pt is not receiving stimulation in her right leg.Reprogramming was unsuccessful.Diagnostics identified high impedance.The pt met with the physician for evaluation.Follow-up revealed, the physician believes there is a kink in the leads at both anchor sites.The pt will undergo surgical intervention to address the issue.

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: benjyna obasuyi ; 6901 preston rd.; plano, TX 75024 ; 9725264659
• MDR Report Key: 3683196
• MDR Text Key: 20856412
• Report Number: 1627487-2014-25118
• 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: 01/23/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/13/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/01/2014
• Device Model Number: 3146
• Device Lot Number: 3719697
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/23/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/01/2012
• 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: IMPLANTED:; SCS IPG: MODEL 3716; IMPLANTED:; SCS ANCHORS: MODEL 1192 (X2); IMPLANTED:; IMPLANTED:; SCS LEADS: MODEL 3166 (X2); SCS EXTENSIONS: MODEL 3341 (X2)
• Patient Outcome(s): Other
• Patient Age: 45 YR