MAUDE Adverse Event Report: ABBOTT MEDICAL INFINITY 5 IMPLANTABLE PULSE GENERATOR; DBS IPG

Model Number	6660
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	09/03/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Date of event is estimated.
Event or Problem Description
It was reported the patient had an infection at the right ipg site.As a result, the patient underwent surgical intervention during which the right ipg and right extension were explanted.The patient's right lead and burr hole cover will be explanted on another day.
Additional 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.
Event or Problem Description
Additional information received indicates that the physician underwent surgical intervention to remove the patient's right lead and extension with no complications.No remaining infection issues were told of.
Additional Manufacturer Narrative
Correction: section h6 investigation conclusions code should have been "22 - known inherent risk of device" instead of "12 - cause traced to device design" in additional report 1.This correction is reflected in this additional report 2.

• Brand Name: INFINITY 5 IMPLANTABLE PULSE GENERATOR
• Common Device Name: DBS IPG
• Manufacturer (Section D): ABBOTT MEDICAL; 6901 preston rd; plano TX 75024
• MDR Report Key: 12511186
• Report Number: 1627487-2021-17130
• Device Sequence Number: 19075771
• Product Code: MHY
• UDI-Device Identifier: 05415067030016
• UDI-Public: 05415067030016
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: P140009
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,consum
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/21/2021

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
• Operator of Device: Health Professional
• Device Expiration Date: 10/03/2020
• Device Model Number: 6660
• Device Catalogue Number: 6660
• Device Lot Number: 6675875
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 09/03/2021
• Supplement Date Received by Manufacturer: 09/27/2021; 10/21/2021
• Initial Report FDA Received Date: 09/22/2021
• Supplement Report FDA Received Date: 10/07/2021; 10/21/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Weight: 91