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

Model Number 3286

Device Problems Fracture (1260); High impedance (1291); Low impedance (2285)

Patient Problem Inadequate Pain Relief (2388)

Event Date 10/04/2021

Event Type  Injury  

Manufacturer Narrative

Date of event is estimated.It is unknown which lead was explanted.Hence, both leads are being reported.The unique device identifier (udi) is not provided because the manufacture date is before sep 24, 2014.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 Description

Related manufacturer reference number: 1627487-2021-17839.It was reported patient experienced loss of therapy due to high and low impedance issues.In turn, surgical intervention took place on (b)(6) 2021 wherein intra-op testing of the leads resulted in one lead with high impedances and the other lead fully functional.The impeded lead was explanted and replaced and other functional lead remained implanted.During explantation of the impeded lead, a lead fracture was observed.The functional lead and new lead were plugged into the existing ipg and therapy was restored post-operatively, reportedly.

• Brand Name: LAMITRODE S-8 LEAD KIT, 60CM LENGTH
• Type of Device: SCS 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: 12685375
• MDR Text Key: 278015823
• Report Number: 1627487-2021-17838
• Device Sequence Number: 1
• Product Code: LGW
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P010032
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 10/22/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/22/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/28/2013
• Device Model Number: 3286
• Device Lot Number: 3467812
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/04/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/16/2011
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: SCS LEAD, MODEL: 3286
• Patient Outcome(s): Other
• Patient Weight: 77