MAUDE Adverse Event Report: ABBOTT MEDICAL KIT IMPLANTABLE SLIM TIP LEAD, 50CM; DRG SLIM TIP LEAD

Model Number MN10450-50A

Device Problem Material Twisted/Bent (2981)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/20/2020

Event Type  Injury  

Manufacturer Narrative

Date of event is estimated.A patient experiencing ineffective stimulation due to autoreducing was reported to abbott.The issue was resolved through lead replacement.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

Related manufacturer reference# 1627487-2020-32178.It was reported the patient underwent surgical intervention to address the autoreducing of one lead.Prior to the procedure it was confirmed this lead was twisted around the other lead making it to difficult to only explant the lead that was having the autoreducing issues.During the procedure, the physician decided to explant this lead.

Manufacturer Narrative

A patient experienced ineffective stimulation due to autoreducing was reported to abbott.As a result, the l1 lead was replaced due to the high impedances and the l4 lead was explanted.Therapy was restored.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.

• Brand Name: KIT IMPLANTABLE SLIM TIP LEAD, 50CM
• Type of Device: DRG SLIM TIP LEAD
• Manufacturer (Section D): ABBOTT MEDICAL; 6901 preston rd; plano TX 75024
• MDR Report Key: 10736745
• MDR Text Key: 213164808
• Report Number: 1627487-2020-32970
• Device Sequence Number: 1
• Product Code: PMP
• UDI-Device Identifier: 05415067027153
• UDI-Public: 05415067027153
• Combination Product (y/n): N
• PMA/PMN Number: P150004
• 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: 03/09/2021

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?: No
• Device Operator: Health Professional
• Device Expiration Date: 05/09/2021
• Device Model Number: MN10450-50A
• Device Catalogue Number: MN10450-50A
• Device Lot Number: 6979485
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 10/09/2020
• Initial Date FDA Received: 10/26/2020
• Supplement Dates Manufacturer Received: 02/25/2021
• Supplement Dates FDA Received: 03/09/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: DRG LEAD.
• Patient Outcome(s): Other
• Patient Weight: 95