MAUDE Adverse Event Report: ABBOTT MEDICAL OCTRODE LEAD KIT, 60CM LENGTH; SCS LEAD

Model Number 3186

Device Problem Disconnection (1171)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/15/2020

Event Type  Injury  

Manufacturer Narrative

Date of event is estimated.The patient's weight was unable to be obtained.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

Device 1 of 3.Reference mfr.Report#: 1627487-2020-49195.Reference mfr.Report#: 3006705815-2020-33398.It was reported the patient was unable to set their ipg into mri mode due to a combination of high and low impedance related to one of the patient's leads.As a result, the patient underwent surgical intervention on (b)(6) 2020.During the procedure, the lead related to the impedance issue was found to be disconnected from the ipg header.In turn, the doctor reconnected the lead to the ipg header.Surgical intervention addressed the patient's issue.Note: both of the patient's leads are being reported because it's unknown which lead was liable.

• Brand Name: OCTRODE 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: 11067480
• MDR Text Key: 223471919
• Report Number: 1627487-2020-49194
• Device Sequence Number: 1
• Product Code: LGW
• UDI-Device Identifier: 05414734401708
• UDI-Public: 05414734401708
• 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: 12/23/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/23/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/21/2010
• Device Model Number: 3186
• Device Catalogue Number: 3186
• Device Lot Number: 119461
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/30/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/21/2008
• 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: MODEL: 3186; MODEL: 3662
• Patient Outcome(s): Other