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

Model Number	3066
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Discomfort (2330)
Date of Event	08/16/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
In the event the device is returned to the manufacturer, the reported event cannot be analyzed via laboratory testing.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 or Problem Description
Device 3 of 4 reference mfr.Report #: 1627487-2018-08581, 1627487-2018-08582, 1627487-2018-08586.It was reported that the patient was experiencing discomfort (sore to the touch) at the trial lead site, after an attempt for removal was unsuccessful by the physician.Reportedly, the physician cut the lead at the exit site but was unable to remove it.The next course of action was undetermined at this time.
Event or Problem Description
Device 2 of 4.Reference mfr.Report#: 1627487-2018-08581, 1627487-2018-08582, 1627487-2018-08586.Follow up revealed that the patient's lead was explanted and a new scs system was implanted, which addressed the issue.

• Brand Name: QUATTRODE TRIAL LEAD WIDE SPACED
• Common Device Name: SCS LEAD
• Manufacturer (Section D): ST. JUDE MEDICAL - NEUROMODULATION; 6901 preston rd; plano TX 75024
• MDR Report Key: 7862441
• Report Number: 1627487-2018-08584
• Device Sequence Number: 1967016
• Product Code: GZF
• UDI-Device Identifier: 05414734406017
• UDI-Public: 05414734406017
• Combination Product (Y/N): N
• Initial Reporter State: AR
• Initial Reporter Country: US
• PMA/510(K) Number: K072462
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/26/2018

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
• Operator of Device: Health Professional
• Device Expiration Date: 04/26/2020
• Device Model Number: 3066
• Device Lot Number: 6424240
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 08/16/2018
• Supplement Date Received by Manufacturer: 09/26/2018
• Initial Report FDA Received Date: 09/10/2018
• Supplement Report FDA Received Date: 10/26/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other