MAUDE Adverse Event Report: ST. JUDE MEDICAL - NEUROMODULATION QUATTRODE LEAD WIDE SPACED, 60 CM; SCS LEAD

Model Number 3166

Device Problem Kinked (1339)

Patient Problems Pain (1994); Inadequate Pain Relief (2388)

Event Date 12/24/2015

Event Type  Injury  

Manufacturer Narrative

(b)(4).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.

Event Description

Device 3 of 3.Reference mfr.Report: 1627487-2016-03170.Reference mfr.Report: 1627487-2016-03171.The patient received two peripheral (off-label) leads and one thoracic lead.The patient experienced loss of stimulation in (b)(6) 2015.Per patient, stimulation could not be restored at that time.X-rays did not reveal any anomalies.In (b)(6) 2016, the patient reported going to the emergency room due to pain.X-rays indicated a kink in one or more leads.Surgical intervention may take place to address the issue.

Event Description

Device 3 of 3: reference mfr.Report: 1627487-2016-03170; reference mfr.Report: 1627487-2016-03171.Follow-up identified the issue was resolved via reprogramming.Effective stimulation has been restored.

• Brand Name: QUATTRODE LEAD WIDE SPACED, 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: 5746438
• MDR Text Key: 48093080
• Report Number: 1627487-2016-03172
• Device Sequence Number: 1
• Product Code: GZF
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K072462
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 06/17/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/23/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/28/2014
• Device Model Number: 3166
• Device Lot Number: 3740322
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/17/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/30/2012
• 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
• Patient Outcome(s): Other
• Patient Age: 53 YR