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

Model Number 3228

Device Problems Fracture (1260); Therapeutic or Diagnostic Output Failure (3023); Migration (4003)

Patient Problem Inadequate Pain Relief (2388)

Event Date 08/02/2021

Event Type  Injury  

Manufacturer Narrative

Date of the event is estimated.

Event Description

It was reported the patient's lead was fractured and had slightly migrated causing ineffective therapy.Surgical intervention took place in which the lead was explanted and replaced 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.

• 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: 12318067
• MDR Text Key: 266379764
• Report Number: 1627487-2021-16289
• Device Sequence Number: 1
• Product Code: LGW
• UDI-Device Identifier: 05414734406246
• UDI-Public: 05414734406246
• 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,health
• Type of Report: Initial,Followup
• Report Date: 08/25/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2017
• Device Model Number: 3228
• Device Catalogue Number: 3228
• Device Lot Number: 5155389
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 07/30/2021
• Initial Date FDA Received: 08/13/2021
• Supplement Dates Manufacturer Received: 08/24/2021
• Supplement Dates FDA Received: 08/25/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Weight: 98