MAUDE Adverse Event Report: ST. JUDE MEDICAL - NEUROMODULATION QUATTRODE LEAD, 3/6MM, 30 CM; SCS LEAD

Model Number 3153

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

Patient Problems Inadequate Pain Relief (2388); No Known Impact Or Consequence To Patient (2692)

Event Date 06/14/2018

Event Type  Injury  

Manufacturer Narrative

The manufacturer 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.The manufacturer defers to the patient's physician regarding medical history.

Event Description

Device 1 of 2; reference mfr.Report#: 1627487-2018-06256.It was reported the patient was receiving ineffective stimulation, and surgical intervention was attempted on (b)(6) 2018 (mfr.Reports #s: 1627487-2018-06209, 1627487-2018-06210, 1627487-2018-06211).No products were implanted or explanted.

Event Description

Device 1 of 2.Reference mfr.Report#: 1627487-2018-06256.Information gathered revealed the patient's leads were explanted and replaced (with different models).The replacement leads were implanted in a different location than prior.

Event Description

Device 1 of 2 reference mfr.Report#: 1627487-2018-06256.Follow-up revealed surgical intervention addressed the patient's issue.

Manufacturer Narrative

The results of the investigation are inconclusive since the device was not returned for analysis.Based on the information received, the cause of the reported incident could not be conclusively determined.

Event Description

Device 1 of 2 reference mfr.Report#: 1627487-2018-06256.

• Brand Name: QUATTRODE LEAD, 3/6MM, 30 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
• Manufacturer Contact: michael mccane ; 9725268297
• MDR Report Key: 7667266
• MDR Text Key: 113341642
• Report Number: 1627487-2018-06255
• 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: consumer
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 02/20/2020

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: 01/28/2014
• Device Model Number: 3153
• Device Lot Number: 3599582
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 06/14/2018
• Initial Date FDA Received: 07/06/2018
• Supplement Dates Manufacturer Received: 08/08/2019; 01/27/2020; 02/02/2020
• Supplement Dates FDA Received: 08/30/2019; 01/27/2020; 02/20/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/24/2012
• 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: MODEL: 1194, SCS ANCHOR (X2); MODEL: 3688, SCS IPG
• Patient Outcome(s): Other