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

Model Number	3240
Medical Device Problem Code	Material Twisted/Bent (2981)
Health Effect - Clinical Code	Inadequate Pain Relief (2388)
Date of Event	02/14/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Date of event is estimated.
Event or Problem Description
Related manufacturer report number 1627487-2022-01150.It was reported that there were high impedances found on the leads.On further investigation, it was seen that the leads were twisted around the ipg, causing the leads to break.In turn, surgical intervention may take place to address the issue.
Event or Problem Description
Additional information revealed that the patient underwent surgical intervention wherein the leads were explanted and replaced.The leads were cut when explanting due to difficulty removing the leads at one part.Postoperatively, the patient has effective therapy.
Additional Manufacturer Narrative
The reported sudden stop of the therapy/high impedance was confirmed.As received, microscopic inspection of both lamitrode4 showed broken wires inside the paddle.The cause of the fracture is consistent with an overstress condition or sudden event the lead was subjected while in vivo.

• Brand Name: LAMITRODE 4 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: 13637670
• Report Number: 1627487-2022-01151
• Device Sequence Number: 2162946
• Product Code: LGW
• UDI-Device Identifier: 05414734402033
• UDI-Public: 05414734402033
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: P010032
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2022
• 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): 04/05/2022

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: 08/10/2021
• Device Model Number: 3240
• Device Catalogue Number: 3240
• Device Lot Number: 7120501
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• 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: 02/14/2022
• Supplement Date Received by Manufacturer: 03/03/2022; 04/04/2022
• Initial Report FDA Received Date: 03/01/2022
• Supplement Report FDA Received Date: 03/17/2022; 04/05/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/11/2019
• 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