MAUDE Adverse Event Report: ST. JUDE MEDICAL - NEUROMODULATION LAMITRODE 44 LEAD KIT, 90CM LENGTH; SCS PADDLE LEAD

Model Number	3262
Medical Device Problem Codes	Impedance Problem (2950); Therapeutic or Diagnostic Output Failure (3023)
Health Effect - Clinical Code	Inadequate Pain Relief (2388)
Date of Event	02/04/2020
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 on the final report.
Event or Problem Description
Manufacturer report number 1627487-2020-01743.It was reported that patient experienced ineffective stimulation due to invalid impedance issue.The device system was explanted, and a new device system was implanted.Therapy was restored post procedure.Patient was stable.
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.

• Brand Name: LAMITRODE 44 LEAD KIT, 90CM LENGTH
• Common Device Name: SCS PADDLE LEAD
• Manufacturer (Section D): ST. JUDE MEDICAL - NEUROMODULATION; 6901 preston rd; plano TX 75024
• MDR Report Key: 10492340
• Report Number: 1627487-2020-30937
• Device Sequence Number: 2147356
• Product Code: LGW
• UDI-Device Identifier: 05414734402132
• UDI-Public: 05414734402132
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: P010032
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2014
• 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): 09/10/2020

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: 10/28/2015
• Device Model Number: 3262
• Device Catalogue Number: 3262
• Device Lot Number: 4317676
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 08/18/2020
• Supplement Date Received by Manufacturer: 09/03/2020
• Initial Report FDA Received Date: 09/04/2020
• Supplement Report FDA Received Date: 09/10/2020
• 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: SCS IPG; SCS IPG
• Outcome Attributed to Adverse Event: Other
• Patient Age: 49 YR
• Patient Weight: 68