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

Model Number MN20450-50

Device Problem Material Fragmentation (1261)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/18/2022

Event Type  Injury  

Event Description

Related manufacturer reference number: 1627487-2023-00148; related manufacturer reference number: 1627487-2023-00153.It was reported that during a revision procedure the leads were stuck and were unable to be removed.

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.Corrected date:d1 - brand name and d4 model number.

Manufacturer Narrative

D1: device information and implant date is unknown.During processing of this incident, attempts were made to obtain complete event and device information.Further information was requested but not received.

Event Description

Additional information received indicates that the leads that were stuck were from 2014 (exact implant date is unknown).Reportedly, only portions of the leads were left implanted.

• Brand Name: KIT IMPLANTABLE LEAD, 50CM
• Type of Device: DRG IMPLANTABLE 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: 16135808
• MDR Text Key: 307062938
• Report Number: 1627487-2023-00152
• Device Sequence Number: 1
• Product Code: PMP
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: P150004
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 02/21/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/11/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 05/12/2021
• Device Model Number: MN20450-50
• Device Lot Number: 6979517
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/17/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/13/2019
• 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