MAUDE Adverse Event Report: ST. JUDE MEDICAL - NEUROMODULATION LAMITRODE S-4 LEAD KIT, 60CM LENGTH; SCS LEAD

Model Number	3246
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Inadequate Pain Relief (2388)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The results/method and conclusion codes along with investigation results will be provided in the final report.
Event or Problem Description
Reference mfr.Report# 1627487-2019-02518, 1627487-2019-02519 (for high impedances).It was reported that the patient had high impedances on the lead and extension during intra-operative testing after an ipg replacement on (b)(6) 2019.It was also noted the other lead had migrated from original location.The lead and extension were explanted and replaced to address the high impedance.The other lead was revised.It was reported that effective therapy was restored post-operatively.

• Brand Name: LAMITRODE S-4 LEAD KIT, 60CM LENGTH
• Common Device Name: SCS LEAD
• Manufacturer (Section D): ST. JUDE MEDICAL - NEUROMODULATION; 6901 preston rd; plano TX 75024
• MDR Report Key: 8376414
• Report Number: 1627487-2019-02521
• Device Sequence Number: 18883661
• Product Code: LGW
• UDI-Device Identifier: 05414734406253
• UDI-Public: 05414734406253
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: P010032
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/05/2019

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: 05/28/2016
• Device Model Number: 3246
• Device Lot Number: 4608105
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 02/12/2019
• Supplement Date Received by Manufacturer: 04/04/2019
• Initial Report FDA Received Date: 02/27/2019
• Supplement Report FDA Received Date: 04/05/2019
• 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: 91