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

Model Number 3286

Device Problem Patient-Device Incompatibility (2682)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 06/02/2021

Event Type  Injury  

Event Description

It was reported that during the patients lead revision procedure on (b)(6) 2021 (related manufacturer reference number: 3006705815-2021-02363) the physician was unable to implant the replacement lead due to scar tissue.The procedure was abandoned without implant.

Manufacturer Narrative

It was reported to abbott that the patient¿s lead implant procedure was abandoned because the physician experienced insertion difficulties due to the patient's scar tissue.The results of the investigation are inconclusive since the lead was not returned for analysis.Based on the information received, the cause of the reported event could not be conclusively determined.

• Brand Name: LAMITRODE S-8 LEAD KIT, 60CM LENGTH
• Type of Device: SCS PADDLE LEAD
• Manufacturer (Section D): ABBOTT MEDICAL; 6901 preston rd; plano TX 75024
• MDR Report Key: 12002086
• MDR Text Key: 256296998
• Report Number: 1627487-2021-14884
• Device Sequence Number: 1
• Product Code: LGW
• UDI-Device Identifier: 05414734402231
• UDI-Public: 05414734402231
• Combination Product (y/n): N
• PMA/PMN Number: P010032
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 08/25/2021

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?: No
• Device Operator: Health Professional
• Device Expiration Date: 02/13/2022
• Device Model Number: 3286
• Device Catalogue Number: 3286
• Device Lot Number: 7370147
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 06/02/2021
• Initial Date FDA Received: 06/15/2021
• Supplement Dates Manufacturer Received: 08/18/2021
• Supplement Dates FDA Received: 08/25/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other