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

Model Number 3228

Device Problems Disconnection (1171); Insufficient Information (3190)

Patient Problems Inadequate Pain Relief (2388); Insufficient Information (4580)

Event Date 03/25/2021

Event Type  Injury  

Manufacturer Narrative

Date of event is estimated.During processing of this complaint, attempts were made to obtain weight but not received.

Event Description

Related manufacturer reference number 3006705815-2021-01623.It was reported the patient's system was explanted and replaced for an unknown reason.

Manufacturer Narrative

D6b - date of explant should have been (b)(6) 2021 instead of (b)(6) 2021.The results of the investigation are inconclusive since the devices were not returned for analysis.Based on the information received, the cause of the reported event could not be conclusively determined.

Event Description

Additional information was received some of the contacts are out of the paddle and in return patient experienced ineffective therapy.

• 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: 11649714
• MDR Text Key: 244916560
• Report Number: 1627487-2021-13002
• Device Sequence Number: 1
• Product Code: LGW
• UDI-Device Identifier: 05415067017253
• UDI-Public: 05415067017253
• 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: 04/23/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/12/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 05/14/2020
• Device Model Number: 3228
• Device Catalogue Number: 3228
• Device Lot Number: 6441630
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/13/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: SCS IPG; SCS IPG
• Patient Outcome(s): Other
• Patient Age: 45 YR