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

Model Number 3228

Device Problems High impedance (1291); Therapeutic or Diagnostic Output Failure (3023)

Patient Problems Headache (1880); Inadequate Pain Relief (2388)

Event Date 12/01/2020

Event Type  Injury  

Manufacturer Narrative

Event and therapy dates are estimated.The results/method and conclusion codes along with the investigation results will be provided in the final report.

Event Description

Related manufacturing reference number: 1627487-2020-49335; related manufacturing reference number: 1627487-2020-49336; related manufacturing reference number: 1627487-2020-49338.It was reported patient experienced ineffective therapy and has headaches.X-rays did not indicate any anomalies.Diagnostics indicated impedance issues.System may be removed at a later date.

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 received, indicated patient underwent surgical intervention.Where in the cervical scs system was explanted.

• 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: 11092343
• MDR Text Key: 224248741
• Report Number: 1627487-2020-49333
• 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,health
• Type of Report: Initial,Followup
• Report Date: 01/19/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/29/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/28/2014
• Device Model Number: 3228
• Device Catalogue Number: 3228
• Device Lot Number: 3677404
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/14/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: MODEL 3386,SCS EXT X 2; MODEL 3660,SCS IPG; MODEL 3386,SCS EXT X 2; MODEL 3660,SCS IPG
• Patient Outcome(s): Other
• Patient Age: 36 YR
• Patient Weight: 113