MAUDE Adverse Event Report: ABBOTT MEDICAL 4CH DBS LEAD, 40CM CONTACT 1.5 SPACE 1.5; DBS LEAD EXTENSION

Model Number 6145

Device Problem High impedance (1291)

Patient Problems Inadequate Pain Relief (2388); Movement Disorder (4412)

Event Date 02/13/2024

Event Type  Injury  

Manufacturer Narrative

Date of event is estimated.Date of implant is unknown.The unique device identifier (udi) is not provided because the lot number is unknown.Initial reporter phone number: +57 604 4441333.

Event Description

Related manufacturer report number: 1627487-2024-07281.It was reported that the patient was experiencing ineffective therapy due to impedance issues on their lead extension.As a result, the patient underwent surgical intervention during which the lead extension was explanted and replaced.During the procedure, the physician was unable to remove the extension from the ipg header since device had rolled screws, so the ipg was explanted and replaced as well.Effective therapy was established post-operatively.

Manufacturer Narrative

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.

Manufacturer Narrative

Correction: section h6 health effect - clinical code should have been "4412 - movement disorder" instead of "2388 - inadequate pain relief" in the initial report and additional report 1.This correction is reflected this in additional report 2.

• Brand Name: 4CH DBS LEAD, 40CM CONTACT 1.5 SPACE 1.5
• Type of Device: DBS LEAD EXTENSION
• 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: 18810099
• MDR Text Key: 336584955
• Report Number: 1627487-2024-07282
• Device Sequence Number: 1
• Product Code: MHY
• Combination Product (y/n): N
• Reporter Country Code: CO
• PMA/PMN Number: P140009
• 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,Followup,Followup
• Report Date: 04/03/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/29/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 6145
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/03/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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
• Patient Outcome(s): Other