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

Model Number	3224
Medical Device Problem Codes	Impedance Problem (2950); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); Inadequate Pain Relief (2388)
Date of Event	10/08/2018
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 2 of 3.Reference mfr.Report: 1627487-2018-10440.Reference mfr.Report: 1627487-2018-10442.It was reported the patient was to undergo scs system replacement for unknown reason.As a result, the physician explanted and replaced the scs system.
Event or Problem Description
Device 2 of 3.Reference mfr.Report: 1627487-2018-10440.Reference mfr.Report: 1627487-2018-10442.Follow up information identified the reason for the system explant and replacement on (b)(6) 2018.The patient¿s ipg was inoperable, and the patient¿s two leads showed invalid impedances.
Event or Problem Description
Device 2 of 3: reference mfr.Report: 1627487-2018-10440, reference mfr.Report: 1627487-2018-10442.Follow up information identified the patient now has effective therapy.
Event or Problem Description
Device 2 of 3.Reference mfr.Report: 1627487-2018-10440.Reference mfr.Report: 1627487-2018-10442.

• Brand Name: EXCLAIM LEAD, 60 CM
• Common Device Name: SCS LEAD
• Manufacturer (Section D): ST. JUDE MEDICAL - NEUROMODULATION; 6901 preston rd; plano TX 75024
• MDR Report Key: 7996086
• Report Number: 1627487-2018-10441
• Device Sequence Number: 203369
• Product Code: LGW
• UDI-Device Identifier: 05414734406178
• UDI-Public: 05414734406178
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: P010032
• 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,Followup,Followup,Followup
• Report Date (Section B): 11/29/2018

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 01/31/2017
• Device Model Number: 3224
• Device Lot Number: 4989998
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 10/08/2018
• Supplement Date Received by Manufacturer: 10/25/2018; 11/06/2018; 11/29/2018
• Initial Report FDA Received Date: 10/23/2018
• Supplement Report FDA Received Date: 10/26/2018; 11/08/2018; 11/29/2018
• 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
• Patient Weight: 77