MAUDE Adverse Event Report: ABBOTT MEDICAL LAMITRODE 88 LEAD KIT, 60CM LENGTH; SCS PADDLE LEAD

Model Number	3214
Medical Device Problem Code	High impedance (1291)
Health Effect - Clinical Code	Inadequate Pain Relief (2388)
Date of Event	11/05/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The event date is estimated.
Event or Problem Description
It was reported the patients lead displayed high impedance.Surgical intervention was undertaken wherein the lead was explanted and replaced.Surgical intervention addressed the issue.
Additional Manufacturer Narrative
The reported event of high impedance was confirmed.As received, the lamitrode tripole 16 lead was complete with multiple broken wires inside the paddle header.The root cause is consistent with the lead being subjected to overstress while in vivo.
Additional Manufacturer Narrative
D4 - additional device information.
Event or Problem Description
Additional information was received indicating the original device information reported was incorrect.

• Brand Name: LAMITRODE 88 LEAD KIT, 60CM LENGTH
• Common Device Name: SCS PADDLE LEAD
• Manufacturer (Section D): ABBOTT MEDICAL; 6901 preston rd; plano TX 75024
• MDR Report Key: 11683149
• Report Number: 1627487-2021-13237
• Device Sequence Number: 4225314
• Product Code: LGW
• UDI-Device Identifier: 05414734406307
• UDI-Public: 05414734406307
• Combination Product (Y/N): N
• Initial Reporter Country: NZ
• PMA/510(K) Number: P010032
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/07/2021

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: 08/16/2020
• Device Model Number: 3214
• Device Catalogue Number: 3214
• Device Lot Number: 6585709
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/21/2021
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 03/31/2021
• Supplement Date Received by Manufacturer: 05/12/2021; 05/20/2021
• Initial Report FDA Received Date: 04/17/2021
• Supplement Report FDA Received Date: 05/19/2021; 06/07/2021
• 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