MAUDE Adverse Event Report: ABBOTT MEDICAL KIT IMPLANTABLE SLIM TIP LEAD, 90CM; DRG LEAD

Model Number MN10450-90A

Device Problem Migration (4003)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/16/2020

Event Type  Injury  

Manufacturer Narrative

Date of event is estimated.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.

Event Description

Related manufacturer reference number: 1627487-2021-00256.It was reported the patient¿s lead had moved under the skin.In turn, surgical intervention was undertaken on (b)(6) 2020 wherein the physician opened the lead incision, pushed the lead deeper and secured it in place.This addressed the issue.It is unknown which lead had moved and revised, therefore both leads are being reported.

• Brand Name: KIT IMPLANTABLE SLIM TIP LEAD, 90CM
• Type of Device: DRG LEAD
• Manufacturer (Section D): ABBOTT MEDICAL; 6901 preston rd; plano TX 75024
• Manufacturer (Section G): ABBOTT MEDICAL; 6901 preston rd; plano TX 75024
• Manufacturer Contact: ronnie shalev ; 6901 preston road; plano, TX 75024 ; 9723098000
• MDR Report Key: 11155842
• MDR Text Key: 226296323
• Report Number: 1627487-2021-00257
• Device Sequence Number: 1
• Product Code: PMP
• UDI-Device Identifier: 05415067027160
• UDI-Public: 05415067027160
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P150004
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 01/12/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/12/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 07/28/2022
• Device Model Number: MN10450-90A
• Device Catalogue Number: MN10450-90A
• Device Lot Number: 7597610
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/16/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/28/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: MN10450-90A, DRG LEAD
• Patient Outcome(s): Other
• Patient Weight: 73