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

Model Number	6661
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	10/14/2020
Type of Reportable Event	Serious Injury
Additional 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 or Problem Description
It was reported the device displayed the end of service (eos) message and it is unknown if the device depleted prematurely.As a result, surgical intervention was undertaken wherein the ipg was explanted and replaced.Effective therapy was restored post operatively.
Additional Manufacturer Narrative
The results of the investigation are inconclusive since the device was not returned for analysis.Based on the information received, the cause of the reported incident could not be conclusively determined.
Additional Manufacturer Narrative
Corrected data.The device should have been non reportable as it met expected longevity.
Event or Problem Description
There were no known allegations of deficiency against the device as it met expected longevity.

• 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: 10804966
• Report Number: 1627487-2020-33258
• Device Sequence Number: 11047394
• Product Code: MHY
• UDI-Device Identifier: 05415067020253
• UDI-Public: 05415067020253
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: P140009
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative,consum
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/12/2020

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 06/02/2019
• Device Model Number: 6661
• Device Catalogue Number: 6661
• Device Lot Number: 6001259
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 11/03/2020
• Supplement Date Received by Manufacturer: 11/03/2020; 11/11/2020
• Initial Report FDA Received Date: 11/06/2020
• Supplement Report FDA Received Date: 11/06/2020; 11/12/2020
• 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: 136