MAUDE Adverse Event Report: ST. JUDE MEDICAL - NEUROMODULATION QUATTRODE LEAD, 3/6MM, 60 CM; SCS LEAD

Model Number 3156

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Complaint, Ill-Defined (2331)

Event Date 08/25/2016

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

Device 1 of 2.Reference mfr report#1627487-2016-04869.It was reported effective therapy was never established with the left occipital lead (model 3166) after a previous lead revision (reference mfr report#1627487-2016-04817).During the previous procedure, the cervical lead (model 3156) was removed from the epidural space, coiled, and left in situ for future use.Follow-up revealed diagnostic testing of the left occipital lead revealed multiple contacts with high impedance measurements.In addition, the patient experienced sharp pain in the left occipital area surgical intervention may be undertaken at a later date to address the issue.

Event Description

Device 1 of 2.Reference mfr report#1627487-2016-04869.Follow-up identified surgical intervention was undertaken during which time both leads were explanted and replaced with new models.Effective stimulation was achieved postoperatively.The issue is resolved.

• Brand Name: QUATTRODE LEAD, 3/6MM, 60 CM
• 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
• MDR Report Key: 5964829
• MDR Text Key: 55204352
• Report Number: 1627487-2016-04868
• 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: Other
• Type of Report: Initial,Followup
• Report Date: 04/26/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/20/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2016
• Device Model Number: 3156
• Device Lot Number: 5132009
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/13/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/22/2015
• 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: MODEL 3341, SCS EXTENSION; MODEL 3771, SCS IPG
• Patient Outcome(s): Other
• Patient Age: 60 YR