MAUDE Adverse Event Report: ST. JUDE MEDICAL - NEUROMODULATION 50CM IMPLANT LEAD KIT, SLIM TIP; DRG LEAD

Model Number	MN10450-50A
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Inadequate Pain Relief (2388)
Date of Event	06/13/2018
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 3: reference mfr.Report#1627487-2018-06385; reference mfr.Report#1627487-2018-06389.It was reported the patient experienced ineffective pain relief due to migration of their drg lead.Reportedly, x-rays confirmed the issue.As a result, surgical intervention was undertaken on (b)(6) 2018 wherein 2 of the 3 original drg leads were explanted and replaced with new models.Postoperatively, stimulation was restored and the issue resolved.Note: all drg leads are being reported as it's unknown which leads contributed to the issue.

• Brand Name: 50CM IMPLANT LEAD KIT, SLIM TIP
• Common Device Name: DRG LEAD
• Manufacturer (Section D): ST. JUDE MEDICAL - NEUROMODULATION; 6901 preston rd; plano TX 75024
• MDR Report Key: 7677536
• Report Number: 1627487-2018-06394
• Device Sequence Number: 1384357
• Product Code: PMP
• UDI-Device Identifier: 05415067025562
• UDI-Public: 05415067025562
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: P150004
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 07/11/2018

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: 04/11/2018
• Device Model Number: MN10450-50A
• Device Lot Number: AB2111
• 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: 06/13/2018
• Initial Report FDA Received Date: 07/11/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: MODEL MN10200, DRG INS
• Outcome Attributed to Adverse Event: Other
• Patient Weight: 95