MAUDE Adverse Event Report: ABBOTT MEDICAL LAMITRODE S-4 LEAD KIT, 60CM LENGTH; SCS LEAD

Model Number	3246
Medical Device Problem Code	High impedance (1291)
Health Effect - Clinical Code	Inadequate Pain Relief (2388)
Date of Event	04/27/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Date of event is estimated.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
Related manufacturer reference number: 3006705815-2021-02396.It was reported the patient was not receiving effective stimulation and diagnostics indicated high impedances.Due to ineffective therapy patient did not charge their ipg as recommended, causing the ipg to become inoperable.In turn, surgical intervention was undertaken wherein the entire scs system including the lead and the ipg was explanted and replaced.This addressed the issue.

• Brand Name: LAMITRODE S-4 LEAD KIT, 60CM LENGTH
• Common Device Name: SCS LEAD
• Manufacturer (Section D): ABBOTT MEDICAL; 6901 preston rd; plano TX 75024
• MDR Report Key: 11828819
• Report Number: 1627487-2021-14059
• Device Sequence Number: 4367617
• Product Code: LGW
• UDI-Device Identifier: 05414734402095
• UDI-Public: 05414734402095
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: P010032
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2009
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 05/14/2021

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: 06/28/2011
• Device Model Number: 3246
• Device Catalogue Number: 3246
• Device Lot Number: 2804941
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/27/2021
• Initial Report FDA Received Date: 05/14/2021
• 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: 93