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

Model Number MN10450-50A

Device Problem Insufficient Information (3190)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/04/2020

Event Type  Injury  

Manufacturer Narrative

The results/ method and conclusion codes along with investigation results will be provided in the final report.Date of event is estimated.

Event Description

Related manufacturer reference numbers: 1627487-2020-48015, 1627487-2020-48017, 1627487-2020-48018.It was reported the system was explanted on an unknown date for an unknown reason.

Event Description

Additional information indicates the system was not removed.The system is still implanted in the patient.No issue reported.

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.Correction: upon review, the device should not have been submitted as a medical device report (mdr) as the event did not indicate a malfunction caused a serious event.

• 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: 10869261
• MDR Text Key: 217147012
• Report Number: 1627487-2020-48016
• Device Sequence Number: 1
• Product Code: PMP
• UDI-Device Identifier: 05415067025531
• UDI-Public: 05415067025531
• 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: 12/14/2020

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: 07/11/2019
• Device Model Number: MN10450-50A
• Device Catalogue Number: MN10450-50A
• Device Lot Number: AB2354
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 11/04/2020
• Initial Date FDA Received: 11/19/2020
• Supplement Dates Manufacturer Received: 12/03/2020
• Supplement Dates FDA Received: 12/14/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: DRG IPG; DRG SLIM TIP LEADX2; DRG IPG; DRG SLIM TIP LEADX2
• Patient Outcome(s): Other
• Patient Weight: 73