MAUDE Adverse Event Report: ABBOTT MEDICAL OCTRODE LEAD KIT, 110CM LENGTH; SCS LEAD

Model Number 3181

Device Problem High impedance (1291)

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

Event Date 04/02/2024

Event Type  Injury  

Manufacturer Narrative

During processing of this incident, attempts were made to obtain complete event and device information.Further information was requested but not received.Additional components potentially involved in the event include: common device name: scs lead, model: 3181 , udi: (b)(4), serial: n/a, batch: 176232.

Event Description

It was reported that during an elective ipg replacement procedure, intra operative impedance check revealed high impedance on 4 different contacts of one of the leads.The patient was returned to or and surgical intervention was undertaken wherein the lead was removed from the ipg, wiped and reinserted to address the issue.Impedance checked reëlected that the high impedance resolved on 3 of the contacts, leaving only high impedance on contact 1.Effective therapy was established post op.Investigation was unable to determine which of the leads had high impedance.

• Brand Name: OCTRODE LEAD KIT, 110CM 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: 19214729
• MDR Text Key: 341409607
• Report Number: 1627487-2024-08161
• Device Sequence Number: 1
• Product Code: LGW
• Combination Product (y/n): N
• Reporter Country Code: NZ
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/30/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/30/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/28/2010
• Device Model Number: 3181
• Device Lot Number: 116232
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/02/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 03/28/2008
• 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: SCS IPG.; SCS LEAD.
• Patient Outcome(s): Other
• Patient Age: 65 YR
• Patient Sex: Male