MAUDE Adverse Event Report: ABBOTT MEDICAL PENTA 3MM LEAD, 60 CM; SCS PADDLE LEAD

Model Number 3228

Device Problem Fracture (1260)

Patient Problem Inadequate Pain Relief (2388)

Event Date 11/11/2016

Event Type  Injury  

Manufacturer Narrative

Date of event is estimated.

Event Description

It was reported that the patient experienced ineffective therapy.Troubleshooting revealed high impedances indicating a possible lead fracture.As a result, surgical intervention may be undertaken to address the issue.

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.

Event Description

Additional information indicates surgical intervention was undertaken on (b)(6) 2021 wherein the entire system was explanted and replaced to address the issue.

• Brand Name: PENTA 3MM LEAD, 60 CM
• Type of Device: SCS PADDLE LEAD
• Manufacturer (Section D): ABBOTT MEDICAL; 6901 preston rd; plano TX 75024
• MDR Report Key: 12490933
• MDR Text Key: 272014119
• Report Number: 1627487-2021-17051
• Device Sequence Number: 1
• Product Code: LGW
• UDI-Device Identifier: 05414734401913
• UDI-Public: 05414734401913
• Combination Product (y/n): N
• PMA/PMN Number: P010032
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,consum
• Type of Report: Initial,Followup
• Report Date: 10/07/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/17/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/28/2013
• Device Model Number: 3228
• Device Catalogue Number: 3228
• Device Lot Number: 3529981
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/01/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Weight: 100