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

Model Number 3228

Device Problems Disconnection (1171); Failure to Deliver Energy (1211)

Patient Problem Inadequate Pain Relief (2388)

Event Date 12/04/2020

Event Type  Injury  

Manufacturer Narrative

Date of event is estimated.The results/method and conclusion codes along with investigation results will be provided in the final report.

Event Description

Related manufacturer reference number: 1627487-2020-49368, 1627487-2020-49369.It was reported the patient experienced a loss of stimulation due to the extensions not being locked down.Surgical intervention took place wherein the extensions were explanted and replaced.Effective therapy was restored.

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: 11096325
• MDR Text Key: 224412857
• Report Number: 1627487-2020-49367
• 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,consum
• Type of Report: Initial,Followup
• Report Date: 01/06/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/30/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 11/28/2016
• Device Model Number: 3228
• Device Catalogue Number: 3228
• Device Lot Number: 4879537
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/05/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: MODEL 3383 X 2 EXTENSION; MODEL 3383 X 2 EXTENSION
• Patient Outcome(s): Other
• Patient Age: 47 YR
• Patient Weight: 82