MAUDE Adverse Event Report: ABBOTT MEDICAL EXCLAIM LEAD, 90 CM; SCS PADDLE LEAD

Model Number 3225

Device Problem Fracture (1260)

Patient Problem Inadequate Pain Relief (2388)

Event Type  Injury  

Manufacturer Narrative

Event date is unknown.During processing of this complaint, attempts were made to obtain complete patient information.

Event Description

Related manufacturer reference number: 1627487-2021-17265.It was reported that the patient was not getting adequate therapy due to lead fracture.There were several invalid impedances on a few contacts.As a result, surgical intervention occurred on (b)(6) 2021 and the leads were explanted and replaced.The patient has effective therapy post operatively.

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: EXCLAIM LEAD, 90 CM
• Type of Device: SCS PADDLE LEAD
• Manufacturer (Section D): ABBOTT MEDICAL; 6901 preston rd; plano TX 75024
• MDR Report Key: 12533189
• MDR Text Key: 273350464
• Report Number: 1627487-2021-17266
• Device Sequence Number: 1
• Product Code: LGW
• UDI-Device Identifier: 05414734401883
• UDI-Public: 05414734401883
• Combination Product (y/n): N
• PMA/PMN Number: K063080
• 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: 09/30/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/27/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 09/28/2014
• Device Model Number: 3225
• Device Catalogue Number: 3225
• Device Lot Number: 3808586
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/28/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: SCS PADDLE LEAD; SCS PADDLE LEAD
• Patient Outcome(s): Other