MAUDE Adverse Event Report: ABBOTT MEDICAL DRG SLIM TIP LEAD

Model Number NMD0006

Device Problem Material Fragmentation (1261)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 02/10/2022

Event Type  Injury  

Manufacturer Narrative

During processing of this incident, attempts were made to obtain complete device information.Unique device identifier (udi #): the udi is unknown because the lot number was not provided.

Event Description

It was reported that during lead replacement procedure while the implanted leads were being explanted, one of the leads lost a clinical contact outside of the l5 foramen.The location of the contact was confirmed through x-ray testing.The physician confirmed visually that the location should not cause any harm to the patient.It was noted that the patient had scar tissue at the l5 location that was likely holding the lead in place.Effective therapy was established post-operative using the patient¿s other implanted lead.

Manufacturer Narrative

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.

• Brand Name: DRG SLIM TIP LEAD
• Type of Device: DRG SLIM TIP 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: 13591733
• MDR Text Key: 286063162
• Report Number: 1627487-2022-01052
• Device Sequence Number: 1
• Product Code: PMP
• 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
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 03/15/2022

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?: Yes
• Device Operator: Health Professional
• Device Model Number: NMD0006
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 02/10/2022
• Initial Date FDA Received: 02/24/2022
• Supplement Dates Manufacturer Received: 03/09/2022
• Supplement Dates FDA Received: 03/16/2022
• 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: IPG; LEAD
• Patient Outcome(s): Other
• Patient Weight: 102 KG