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

Model Number MN10450-50A

Device Problem Material Fragmentation (1261)

Patient Problem Implant Pain (4561)

Event Date 07/26/2022

Event Type  Injury  

Event Description

Related manufacturer reference number: 1627487-2022-04539.It was reported the patient is experiencing increased pain at the lead site wherein a drg lead fragment remains implanted in the patient which could not be retrieved from a previous explantation.In turn, surgical intervention may be pending to address the issue.It is unknown which lead remains implanted in the patient.Therefore both leads are being reported.

Manufacturer Narrative

Date of event is estimated.

Manufacturer Narrative

It was reported the patient is experiencing increased pain at the lead site wherein a drg lead fragment remains implanted in the patient which could not be retrieved from a previous explanation.No intervention is planned at this time.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.Please note this report submission is not late.The report is resubmitted per the request from the fda, due to missing 3rd acknowledgement.This is caused by an fda esg server issue from september 21 ¿ 23, 2022.This issue is documented in helpticket (b)(4).The initial submission attempt was performed on 23 september 2022.

• Brand Name: KIT IMPLANTABLE SLIM TIP LEAD, 50CM
• 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: 15263619
• MDR Text Key: 298278549
• Report Number: 1627487-2022-04538
• Device Sequence Number: 1
• Product Code: PMP
• UDI-Device Identifier: 05415067027153
• UDI-Public: 05415067027153
• 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: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 10/19/2022

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: 08/21/2020
• Device Model Number: MN10450-50A
• Device Catalogue Number: MN10450-50A
• Device Lot Number: 6599208
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 07/26/2022
• Initial Date FDA Received: 08/21/2022
• Supplement Dates Manufacturer Received: 09/14/2022
• Supplement Dates FDA Received: 10/19/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/22/2018
• 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: DRG IPG
• Patient Outcome(s): Other
• Patient Sex: Female
• Patient Weight: 104 KG