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

Model Number	3288
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
Event or Problem Description
It was reported the patients lead displayed high impedance on all contacts resulting in ineffective therapy.As a result, surgical intervention was undertaken wherein the lead was explanted and replaced.Therapy was restored following the procedure.
Additional Manufacturer Narrative
The event of high impedance was reported to abbott.Patient has not met with surgeon.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.
Additional Manufacturer Narrative
The reported event was confirmed for high impedance.Microscopic inspection identified all broken wires inside the paddle/header.The root cause is consistent with overstress condition the paddle may have been subjected to while in vivo.

• 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
• Manufacturer (Section G): ABBOTT MEDICAL; 6901 preston rd; plano TX 75024
• Manufacturer Contact: ronnie shalev ; 6901 preston road; plano, TX 75024 ; 9723098000
• MDR Report Key: 12364486
• Report Number: 1627487-2021-16499
• Device Sequence Number: 4116098
• 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: 2019
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/23/2021

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: 09/18/2020
• Device Model Number: 3288
• Device Catalogue Number: 3288
• Device Lot Number: 6649816
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/05/2021
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/10/2021
• Supplement Date Received by Manufacturer: 09/01/2021; 11/17/2021
• Initial Report FDA Received Date: 08/25/2021
• Supplement Report FDA Received Date: 09/07/2021; 11/23/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/19/2018
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown