MAUDE Adverse Event Report: ABBOTT MEDICAL PENTA 3MM LEAD, 60 CM; SCS PADDLE LEAD

Model Number 3228

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

Patient Problem Post Operative Wound Infection (2446)

Event Date 08/01/2021

Event Type  Injury  

Manufacturer Narrative

Date of event is estimated.

Event Description

Related manufacturer reference number: 1627487-2021-16342.Related manufacturer reference number: 1627487-2021-16344.It was reported that patient experienced discomfort at the lead site.Company manufacturer examined the location and reported that infection was observed at the lead and exit site.Patient was treated with iv antibiotics and hospitalized.As a result, to address the issue patient¿s system was explanted.Infection has resolved and patient is stable.

Manufacturer Narrative

A review of the lot history record identified no manufacturing nonconformities issued to the reported device that would have contributed to this event.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: PENTA 3MM LEAD, 60 CM
• Type of Device: SCS PADDLE 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: 12330737
• MDR Text Key: 266855797
• Report Number: 1627487-2021-16341
• Device Sequence Number: 1
• Product Code: LGW
• UDI-Device Identifier: 05415067017253
• UDI-Public: 05415067017253
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P010032
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 08/19/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/17/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 03/01/2023
• Device Model Number: 3228
• Device Catalogue Number: 3228
• Device Lot Number: 7857820
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/17/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/01/2021
• 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: MODEL 3383 X 2
• Patient Outcome(s): Hospitalization; Other
• Patient Weight: 68