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

Model Number	6661
Medical Device Problem Code	Therapeutic or Diagnostic Output Failure (3023)
Health Effect - Clinical Code	Numbness (2415)
Date of Event	01/07/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Date of event is estimated.Further information was requested but not received.
Event or Problem Description
Related manufacturer report 1627487-2021-00456.It was reported that the patient was experience numbness in their hand.Programming changes were attempted however they were unsuccessful.Both implantable pulse generators (ipg) were explanted as a result and a new device was implanted.There were no complications during the procedure.Patient was stable.
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.

• 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: 11220777
• Report Number: 1627487-2021-00455
• Device Sequence Number: 13744938
• 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: 2017
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/27/2021

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: 03/07/2018
• Device Model Number: 6661
• Device Catalogue Number: 6661
• Device Lot Number: 5409375
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 01/07/2021
• Supplement Date Received by Manufacturer: 01/22/2021
• Initial Report FDA Received Date: 01/24/2021
• Supplement Report FDA Received Date: 01/27/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: DBS IPG
• Outcome Attributed to Adverse Event: Other