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

Model Number	3246
Medical Device Problem Code	Therapeutic or Diagnostic Output Failure (3023)
Health Effect - Clinical Code	Inadequate Pain Relief (2388)
Date of Event	02/27/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Date of event is estimated.The results/method and conclusion codes along with investigation results will be provided in the final report.
Event or Problem Description
Reference manufacturer numbers: 1627487-2020-02847, 1627487-2020-02848, 3006705815-2020-01231.It was reported the patient experienced ineffective therapy from their scs system.The patient stated that they had a motor vehicle accident about 5 months prior, but could not recall when therapy became ineffective.In turn, the patient underwent surgical intervention wherein the scs system was explanted and replaced to address the issue.Note: since it is not known which device is causing the issue, all possible devices are being reported on.
Additional Manufacturer Narrative
The reported event of ineffective stimulation was not confirmed.As received, the paddle lead cut into multiple segments consistent with explant damage.Microscopic inspection did not reveal any anomaly.No root cause was identified for the reported.

• Brand Name: LAMITRODE S-4 LEAD KIT, 60CM LENGTH
• Common Device Name: SCS PADDLE LEAD
• Manufacturer (Section D): ST. JUDE MEDICAL - NEUROMODULATION; 6901 preston rd; plano TX 75024
• MDR Report Key: 9844738
• Report Number: 1627487-2020-02846
• Device Sequence Number: 16328786
• 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
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/28/2020

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 Catalogue Number: 3246
• Device Lot Number: 4608105
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/25/2020
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 02/27/2020
• Supplement Date Received by Manufacturer: 04/23/2020
• Initial Report FDA Received Date: 03/17/2020
• Supplement Report FDA Received Date: 04/28/2020
• 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 Age: 44 YR
• Patient Weight: 82