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

Model Number 3163

Device Problem Use of Device Problem (1670)

Patient Problem Inadequate Pain Relief (2388)

Event Date 08/19/2022

Event Type  Injury  

Event Description

Related manufacturer reference number: 3006705815-2022-16418, 1627487-2022-04900.It was reported that during ipg explant procedure on (b)(6) 2022 (related manufacturer reference number: 3006705815-2022-16418), the leads were cut and left in situ.Surgical intervention may be undertaken to address this issue.

Manufacturer Narrative

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 WIDE SPACED, 30 CM
• Type of Device: SCS PERCUTANEOUS 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: ronnie shalev ; 6901 preston road; plano, TX 75024 ; 9723098000
• MDR Report Key: 15397075
• MDR Text Key: 299660505
• Report Number: 1627487-2022-04901
• Device Sequence Number: 1
• Product Code: GZB
• 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,Followup
• Report Date: 11/10/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/09/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 08/28/2012
• Device Model Number: 3163
• Device Catalogue Number: 3163
• Device Lot Number: 3179689
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/28/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/10/2010
• 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 Age: 50 YR
• Patient Sex: Male
• Patient Weight: 95 KG