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

Model Number MN20450-50A

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Post Operative Wound Infection (2446)

Event Date 09/28/2021

Event Type  Injury  

Event Description

Related manufacturer report numbers (b)(4).It was reported that the patient noticed some pus at the lead site.It was confirmed that there was an infection at the lead site.In turn, surgical intervention was undertaken wherein the system was explanted.The patient is currently hospitalized and on iv antibiotics.

Event Description

Additional information revealed that the infection has resolved.

Manufacturer Narrative

The reported issue for ¿infection¿ cannot be confirmed through product analysis testing.Production records pertinent to packaging and sterility were reviewed for the returned product and no nonconformances were found.Analysis of the returned lead found it had been cut during the explant procedure resulting in a stimulation end segment (47.2cm) and a terminal end segment (3.4cm).

• Brand Name: KIT IMPLANTABLE SLIM TIP LEAD, 50CM
• 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: 12617461
• MDR Text Key: 275984556
• Report Number: 1627487-2021-17651
• 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: 12/09/2021

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: 12/03/2022
• Device Model Number: MN20450-50A
• Device Lot Number: 7751696
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/05/2021
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 09/28/2021
• Initial Date FDA Received: 10/12/2021
• Supplement Dates Manufacturer Received: 10/16/2021; 12/09/2021
• Supplement Dates FDA Received: 11/01/2021; 12/09/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/03/2020
• 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: MN20450-50A, DRG LEAD (2); MN20450-50A, DRG LEAD (2)
• Patient Outcome(s): Hospitalization; Other
• Patient Sex: Male