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

Model Number 3151

Device Problem Detachment of Device or Device Component (2907)

Patient Problem Inadequate Pain Relief (2388)

Event Date 07/02/2014

Event Type  Injury  

Event Description

It was reported during the pt's procedure to replace his scs ipg due to end-of-life, the physician noticed the pt's scs lead appeared to be coming apart.The physician explanted and replaced the lead.The pt reported receiving effective stimulation therapy postoperative.

Manufacturer Narrative

Evaluation: results - visual inspection of the returned lead revealed a kink in the lead body with all internal wires broken.The reported event was confirmed.The lead damage is consistent with an overstress condition the lead was subjected to while implanted in the pt.Sjm has limited information related to the patient's medical history and 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: QUATTRODE
• Type of Device: SCS LEAD
• Manufacturer (Section D): ST JUDE MEDICAL - NEUROMODULATION; plano TX
• Manufacturer Contact: arnie ochoa ; 6901 preston rd.; plano, TX 75024 ; 9723098090
• MDR Report Key: 3979965
• MDR Text Key: 15182552
• Report Number: 1627487-2014-02517
• 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: 07/02/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/24/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/01/2009
• Device Model Number: 3151
• Device Lot Number: 171552
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 07/09/2014
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 07/02/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/01/2007
• 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 3643MI; IMPLANT DATE:
• Patient Outcome(s): Other
• Patient Age: 71 YR