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

Model Number 3153

Device Problems High impedance (1291); Inappropriate/Inadequate Shock/Stimulation (1574); Device Operates Differently Than Expected (2913)

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

Event Date 01/15/2014

Event Type  Injury  

Event Description

The patient had two leads implanted with the same lot number.It was reported the patient was experiencing ineffective stimulation.A sjm rep met with the patient and upon interrogation auto reduction was noted.The sjm rep was able to get coverage but patient experienced a surging sensation when lead was activated.Lead diagnostics showed high impedance on multiple contacts.The patient's leads were replaced with new ones, which resolved 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; 6901 preston rd.; plano TX 75024
• Manufacturer (Section G): ST. JUDE MEDICAL- NEUROMODULATION; 6901 preston rd.; plano TX 75024
• Manufacturer Contact: tanja hoffman ; 6901 preston rd.; plano, TX 75024 ; 9723098520
• MDR Report Key: 3649766
• MDR Text Key: 15204605
• Report Number: 1627487-2014-26097
• 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: 01/15/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/06/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/01/2015
• Device Model Number: 3153
• Device Lot Number: 4046671
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/15/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/01/2013
• 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: IMPLANT DATE:; SCS ANCHOR: MODEL 1194; IMPLANT DATE:; SCS IPG: MODEL 3688; SCS EXTENSION: MODEL 3343; IMPLANT DATE:
• Patient Outcome(s): Other
• Patient Age: 66 YR