MAUDE Adverse Event Report: ST. JUDE MEDICAL - NEUROMODULATION LAMITRODE S-8 LEAD KIT, 90CM LENGTH; SCS LEAD

Model Number	3268
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Inadequate Pain Relief (2388)
Date of Event	02/19/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
Reference manufacturer report number: 1627487-2019-06617.Reference manufacturer report number: 1627487-2019-06619.Reference manufacturer report number: 1627487-2019-06621.It was reported the patient experienced ineffective stimulation.In turn, reprogramming was unable to resolve the issue.As a result, surgical intervention may be pending.
Additional Manufacturer Narrative
The results of the investigation are inconclusive since the device was not returned for analysis.Based on the information received, the cause of the reported incident could not be conclusively determined.
Event or Problem Description
Reference manufacturer report number: 1627487-2019-06617; reference manufacturer report number: 1627487-2019-06619; reference manufacturer report number: 1627487-2019-06621.Further follow-up indicates the patient underwent surgical intervention on (b)(6) 2019.During which, the patient's 3268 lead was disconnected from the ipg but remains implanted in the patient.The ipg was explanted and replaced.Surgical intervention addressed the issue.

• Brand Name: LAMITRODE S-8 LEAD KIT, 90CM LENGTH
• Common Device Name: SCS LEAD
• Manufacturer (Section D): ST. JUDE MEDICAL - NEUROMODULATION; 6901 preston rd; plano TX 75024
• MDR Report Key: 8678206
• Report Number: 1627487-2019-06614
• Device Sequence Number: 1860556
• Product Code: LGW
• UDI-Device Identifier: 05414734402194
• UDI-Public: 05414734402194
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: P010032
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2013
• Reporter Type: Manufacturer
• Report Source: company representative,consum
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/01/2019

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: 08/28/2014
• Device Model Number: 3268
• Device Lot Number: 3776062
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 05/23/2019
• Supplement Date Received by Manufacturer: 06/18/2019
• Initial Report FDA Received Date: 06/07/2019
• Supplement Report FDA Received Date: 07/01/2019
• 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 3189(X2), SCS LEAD; MODEL 3788, SCS IPG
• Outcome Attributed to Adverse Event: Other
• Patient Age: 40 YR
• Patient Weight: 91