MAUDE Adverse Event Report: ABBOTT MEDICAL INFINITY 7 IMPLANTABLE PULSE GENERATOR; DBS IPG

Model Number 6663

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

Patient Problems Hypersensitivity/Allergic reaction (1907); Pocket Erosion (2013)

Event Date 03/01/2021

Event Type  Injury  

Manufacturer Narrative

Date of event is estimated.

Event Description

It was reported the patient was suspected to have an infection and/or allergic reaction at the ipg site.The patient reported the ipg site was sensitive and the ipg was eroding through ipg pocket site with only a single layer of skin keeping the ipg in.In turn, surgical intervention was undertaken on (b)(6) 2021 wherein the ipg pocket site was relocated.The patient was treated with iv antibiotics and oral antibiotics post-procedure to prevent an infection.Additional information requested but not received.

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: INFINITY 7 IMPLANTABLE PULSE GENERATOR
• Type of Device: DBS IPG
• Manufacturer (Section D): ABBOTT MEDICAL; 6901 preston rd; plano TX 75024
• MDR Report Key: 11661589
• MDR Text Key: 245334299
• Report Number: 1627487-2021-13132
• Device Sequence Number: 1
• Product Code: MHY
• UDI-Device Identifier: 05415067020277
• UDI-Public: 05415067020277
• Combination Product (y/n): N
• PMA/PMN Number: P140009
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 07/01/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/13/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 03/15/2018
• Device Model Number: 6663
• Device Catalogue Number: 6663
• Device Lot Number: 5414638
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/30/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other