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

Model Number 6661

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

Patient Problem Implant Pain (4561)

Event Date 02/18/2021

Event Type  Injury  

Manufacturer Narrative

Date of event is estimated.The results/method and conclusion codes along with investigation results will be provided in the final report.

Event Description

Related manufacturer reference number: 1627487-2021-01838.It was reported that the patient experienced pain at the ipg sites.As a result, surgical intervention was undertaken on (b)(6) 2021 wherein both ipgs were explanted and only one ipg was placed and relocated.Issue resolved.

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 5 IMPLANTABLE PULSE GENERATOR
• Type of Device: DBS IPG
• Manufacturer (Section D): ABBOTT MEDICAL; 6901 preston rd; plano TX 75024
• MDR Report Key: 11429639
• MDR Text Key: 238319618
• Report Number: 1627487-2021-01837
• Device Sequence Number: 1
• Product Code: MHY
• UDI-Device Identifier: 05415067020253
• UDI-Public: 05415067020253
• 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,consum
• Type of Report: Initial,Followup
• Report Date: 05/06/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/07/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 07/10/2021
• Device Model Number: 6661
• Device Catalogue Number: 6661
• Device Lot Number: 7066788
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/06/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: DBS IPG
• Patient Outcome(s): Other
• Patient Age: 76 YR
• Patient Weight: 45