MAUDE Adverse Event Report: ABBOTT MEDICAL LAMITRODE S-8 LEAD KIT, 60CM LENGTH; SCS PADDLE LEAD

Model Number	3286
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	12/03/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported during an ipg pocket revision in (b)(6) 2021 the lead was flipped.Surgical intervention took place on (b)(6) 2021 wherein the physician tried to rotate the lead but was unable to.Physician attempted to remove the lead but when doing so the thread frayed.Part of the lead remains inside the vertebral canal.Surgical intervention may take place at a later date.
Additional Manufacturer Narrative
Date of event is estimated.Initial reporter phone number: (b)(6).
Event or Problem Description
Additional information received indicates the partial lead was explanted and replaced with two leads.Effective therapy was established.
Additional Manufacturer Narrative
It was reported to abbott that during an ipg pocket revision the lead was flipped.Surgical intervention took place wherein the physician tried to rotate the lead but was unable to.Physician attempted to remove the lead but when doing so the thread frayed.Part of the lead remains inside the vertebral canal.The partial lead was explanted and replaced with two leads.Effective therapy was established.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 S-8 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: 13010027
• Report Number: 1627487-2021-18925
• Device Sequence Number: 19264032
• Product Code: LGW
• UDI-Device Identifier: 05415067017833
• UDI-Public: 05415067017833
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• PMA/510(K) Number: P010032
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 01/10/2022

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 11/30/2017
• Device Model Number: 3286
• Device Catalogue Number: 3286
• Device Lot Number: 5324581
• Was Device Available for Evaluation?: No
• 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: 12/03/2021
• Supplement Date Received by Manufacturer: 12/13/2021; 01/10/2022
• Initial Report FDA Received Date: 12/15/2021
• Supplement Report FDA Received Date: 12/17/2021; 01/10/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/14/2015
• 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