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

Model Number MN20450-50AU

Device Problems Material Fragmentation (1261); Use of Device Problem (1670)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/23/2020

Event Type  Injury  

Manufacturer Narrative

The results/method and conclusion codes along with investigation results will be provided in the final report.Further information requested but not received.

Event Description

Related manufacturer reference number: 1627487-2020-33385.Related manufacturer reference number: 1627487-2020-33386.Related manufacturer reference number: 1627487-2020-33387.It was reported that the patient's lead revision (related manufacturer reference number: 1627487-2020-47703) was abandoned.Reportedly, the physician had great difficulty removing the patient's leads because they were intertwined with each other, as well as the presence of fibrous tissue around the leads.As a result, one partial lead and one contact was left implanted in the patient.

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: KIT IMPLANTABLE LEAD, 50CM, AU
• Type of Device: DRG LEAD
• Manufacturer (Section D): ABBOTT MEDICAL; 6901 preston rd; plano TX 75024
• MDR Report Key: 10825370
• MDR Text Key: 215882015
• Report Number: 1627487-2020-33384
• Device Sequence Number: 1
• Product Code: PMP
• 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,foreig
• Type of Report: Initial,Followup
• Report Date: 12/10/2020

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: 06/30/2015
• Device Model Number: MN20450-50AU
• Device Lot Number: AB1323
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 10/23/2020
• Initial Date FDA Received: 11/11/2020
• Supplement Dates Manufacturer Received: 11/29/2020
• Supplement Dates FDA Received: 12/10/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: MN20450-50AU X 3
• Patient Outcome(s): Other