MAUDE Adverse Event Report: ABBOTT MEDICAL CURVED NEEDLE; DRG CURVED NEEDLE

Model Number MN14000

Device Problem Material Fragmentation (1261)

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

Event Date 06/08/2017

Event Type  Injury  

Event Description

It was reported that during the patient's lead replacement procedure a foreign object was discovered inside the patient.The physician was able to successfully retrieve the foreign object and explant it and the procedure was completed.Stimulation was reportedly restored postoperatively.

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.

• Brand Name: CURVED NEEDLE
• Type of Device: DRG CURVED NEEDLE
• 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: 15342090
• MDR Text Key: 299138291
• Report Number: 1627487-2022-04779
• Device Sequence Number: 1
• Product Code: PMP
• UDI-Device Identifier: 05415067025708
• UDI-Public: 05415067025708
• 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: 09/07/2022

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 Model Number: MN14000
• Device Catalogue Number: MN14000
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 08/12/2022
• Initial Date FDA Received: 09/01/2022
• Supplement Dates Manufacturer Received: 09/07/2022
• Supplement Dates FDA Received: 09/07/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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; DRG LEAD (X2)
• Patient Outcome(s): Other
• Patient Sex: Male
• Patient Weight: 95 KG