MAUDE Adverse Event Report: ABBOTT MEDICAL QUATTRODE LEAD, 3/4MM, 60 CM; SCS LEAD

Model Number 3146

Device Problem Use of Device Problem (1670)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 10/24/2023

Event Type  Injury  

Event Description

Related manufacturer reference number: 1627487-2023-05392.Related manufacturer reference number: 1627487-2023-05393.Related manufacturer reference number: 1627487-2023-05394.It was reported that during a procedure of ipg explant (3006705815-2023-06925), physician cut all the wires above the battery and in the area of the battery pocket on (b)(6) 2023 and then left it implanted and non-functional.

Manufacturer Narrative

The unique device identifier (udi) is not provided because the manufacture date is before sep 24, 2014.Based on the information provided a device problem was not identified, as a result a conclusive cause for the reported patient effect, and the relationship to the product, if any, cannot be determined.

• Brand Name: QUATTRODE LEAD, 3/4MM, 60 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: 18115349
• MDR Text Key: 327879222
• Report Number: 1627487-2023-05390
• Device Sequence Number: 1
• Product Code: LGW
• 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: 11/10/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/10/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 09/04/2004
• Device Model Number: 3146
• Device Lot Number: 15272
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/25/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/05/2002
• 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
• Patient Sex: Male