MAUDE Adverse Event Report: ST. JUDE MEDICAL - NEUROMODULATION QUATTRODE LEAD WIDE SPACED, 30 CM; SCS LEAD

Model Number 3163

Device Problem Kinked (1339)

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

Event Date 12/24/2015

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

Device 2 of 3.Reference mfr.Report: 1627487-2016-03170; reference mfr.Report: 1627487-2016-03172.The patient received two peripheral (off-label) leads and one thoracic lead.The patient experienced loss of stimulation in (b)(6) of 2015.Per patient, stimulation could not be restored at that time.X-rays did not reveal any anomalies.In (b)(6) of 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 2 of 3: reference mfr.Report: 1627487-2016-03170; reference mfr.Report: 1627487-2016-03172.Follow-up identified the issue was resolved via reprogramming.Effective stimulation has been restored.

• Brand Name: QUATTRODE LEAD WIDE SPACED, 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
• MDR Report Key: 5746437
• MDR Text Key: 48093140
• Report Number: 1627487-2016-03171
• 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: 12/28/2015
• Device Model Number: 3163
• Device Lot Number: 4391101
• 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: 12/26/2013
• 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
• Patient Outcome(s): Other
• Patient Age: 53 YR