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	Muscle Stimulation (1412)
Date of Event	06/07/2018
Type of Reportable Event	Serious Injury
Additional 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 or Problem Description
Device 4 of 4.Reference mfr report#1627487-2018-05827, reference mfr report#1627487-2018-05840, reference mfr report#1627487-2018-05842.It was reported that the patient experienced muscle stimulation after the supraorbital trial leads were implanted.Reportedly, patient went to surgery to re-position the leads and is experiencing only muscle stimulation from the leads post-operatively.Patient had a failed trial.Initial reporter information (patient) is unknown at this time.

• 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: 7652873
• Report Number: 1627487-2018-05845
• Device Sequence Number: 16583048
• Product Code: GZB
• UDI-Device Identifier: 05414734406017
• UDI-Public: 05414734406017
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: P010032
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,consum
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 06/29/2018

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: 01/24/2020
• Device Model Number: 3066
• Device Lot Number: 6289689
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/07/2018
• Initial Report FDA Received Date: 06/29/2018
• 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