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

Model Number 3186

Device Problem Use of Device Problem (1670)

Patient Problems Inadequate Pain Relief (2388); Foreign Body In Patient (2687)

Event Date 02/26/2024

Event Type  Injury  

Manufacturer Narrative

B3-date of event is estimated.During processing of this incident, attempts were made to obtain complete patient information.Further information was requested but not received.(patient weight is unknown) 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

It was reported the patient had unrelated surgery that ended up cutting the lead of patient's system.The investigation was unable to determine which of the lead contributed to the event.Next course of action is unknown.

Manufacturer Narrative

Correction: section h-10- the following verbiage was inadvertently omitted from the initial report: the allegation is against 1 of 2 leads; however, it is unknown which lead, therefore, all potential components are being listed.Additional components potentially involved in the event include: common device name: scs lead, model: 3186, udi: (b)(6), serial: unknown, batch: 3498065.

• 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: heidi syndergaard ; 6901 preston road; plano, TX 75024 ; 9723098000
• MDR Report Key: 19000533
• MDR Text Key: 338878010
• Report Number: 1627487-2024-07743
• Device Sequence Number: 1
• Product Code: LGW
• UDI-Device Identifier: 05414734406130
• UDI-Public: 05414734406130
• 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: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/28/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/28/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 09/28/2013
• Device Model Number: 3186
• Device Lot Number: 3498065
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/05/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/21/2011
• 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 ANCHOR (X2); SCS IPG; SCS LEAD
• Patient Outcome(s): Other
• Patient Sex: Male