MAUDE Adverse Event Report: ABBOTT MEDICAL QUATTRODE LEAD WIDE SPACED, 30 CM; SCS LEAD

Model Number 3163

Device Problem High impedance (1291)

Patient Problem Inadequate Pain Relief (2388)

Event Date 03/06/2024

Event Type  Injury  

Manufacturer Narrative

Further information has been requested but not yet received.Date of event is estimated.

Event Description

Related manufacturer reference number: 1627487-2024-07730.It was reported that following multiple falls patient experienced ineffective therapy, both patients leads have high impedances and patient is unable to enter mri mode.As a result, surgical intervention may be undertaken to address the issue.

• Brand Name: QUATTRODE LEAD WIDE SPACED, 30 CM
• 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: 18977955
• MDR Text Key: 338589258
• Report Number: 1627487-2024-07731
• Device Sequence Number: 1
• Product Code: LGW
• UDI-Device Identifier: 05414734406093
• UDI-Public: 05414734406093
• 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: 03/26/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/26/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 03/28/2016
• Device Model Number: 3163
• Device Lot Number: 4496441
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/06/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/03/2014
• 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
• Patient Outcome(s): Other
• Patient Sex: Male
• Patient Weight: 98 KG