MAUDE Adverse Event Report: ST. JUDE MEDICAL - NEUROMODULATION INFINITY 5 IMPLANTABLE PULSE GENERATOR; DBS IPG

Model Number	6661
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Pocket Erosion (2013)
Date of Event	09/02/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The date of event is estimated.The method, results and conclusion codes along with the investigation results will be provided in the final report.
Event or Problem Description
It was reported that the patient experienced erosion at the ipg pocket site in the patient's left chest.
Event or Problem Description
Follow-up information confirmed the during the revision, the ipg was repositioned deeper in the pocket to resolve this issue.
Additional Manufacturer Narrative
A case of erosion was reported to abbott.The ipg was revised and the issue was resolved.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 event could not be conclusively determined.
Event or Problem Description
Follow up information received that the patient underwent a revision on (b)(6) 2020.

• Brand Name: INFINITY 5 IMPLANTABLE PULSE GENERATOR
• Common Device Name: DBS IPG
• Manufacturer (Section D): ST. JUDE MEDICAL - NEUROMODULATION; 6901 preston rd; plano TX 75024
• MDR Report Key: 10540813
• Report Number: 1627487-2020-31494
• Device Sequence Number: 3110701
• Product Code: MHY
• UDI-Device Identifier: 05415067020253
• UDI-Public: 05415067020253
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: P140009
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 12/11/2020

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 02/24/2021
• Device Model Number: 6661
• Device Catalogue Number: 6661
• Device Lot Number: 6865520
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 09/02/2020
• Supplement Date Received by Manufacturer: 10/28/2020; 11/30/2020
• Initial Report FDA Received Date: 09/16/2020
• Supplement Report FDA Received Date: 11/11/2020; 12/12/2020
• 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 Age: 63 YR
• Patient Weight: 65