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

Model Number MN10450-50A

Device Problem Use of Device Problem (1670)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/20/2020

Event Type  Injury  

Manufacturer Narrative

During processing of this complaint, attempts were made to obtain weight but not received.Date of event is estimated.The results/method and conclusion codes along with investigation results will be provided in the final report.

Event Description

Related manufacturer reference number: 1627487-2020-48560, 1627487-2020-48562.It was reported patient¿s lead was explanted due to exposure through skin.During the procedure two leads had migrated.As a result, both leads were explanted and replaced.It is unknown which lead is related to the issue.Therefore, all the suspected lead are being reported.

Manufacturer Narrative

Based on the information provided, a device problem was not identified.As a result, a conclusive cause for the reported patient effect, and the relationship to the product, if any, cannot be 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: 10948774
• MDR Text Key: 219860215
• Report Number: 1627487-2020-48561
• 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,consum
• Type of Report: Initial,Followup
• Report Date: 01/18/2021

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: 05/22/2021
• Device Model Number: MN10450-50A
• Device Catalogue Number: MN10450-50A
• Device Lot Number: 6998318
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 11/20/2020
• Initial Date FDA Received: 12/04/2020
• Supplement Dates Manufacturer Received: 01/17/2021
• Supplement Dates FDA Received: 01/18/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: DRG SLIM TIP LEADX2
• Patient Outcome(s): Other