MAUDE Adverse Event Report: ABBOTT MEDICAL INFINITY¿ 5 IMPLANTABLE PULSE GENERATOR; IPG, 5.3 AH, DBS

Model Number 6660

Device Problems Battery Problem (2885); Insufficient Information (3190)

Patient Problems Inadequate Pain Relief (2388); Insufficient Information (4580)

Event Date 11/15/2022

Event Type  Injury  

Manufacturer Narrative

Date of event is estimated.During processing of this incident, attempts were made to obtain complete patient information.Further information was requested but not received.(patient weight is unknown).

Event Description

It was reported the patient had her left dbs ipg replaced on (b)(6) 2022 because of unknown reasons.

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.

Event Description

It was reported that the ipg was replaced due to end of life.

• Brand Name: INFINITY¿ 5 IMPLANTABLE PULSE GENERATOR
• Type of Device: IPG, 5.3 AH, DBS
• Manufacturer (Section D): ABBOTT MEDICAL; 6901 preston rd; plano TX 75024
• Manufacturer (Section G): ABBOTT MEDICAL; 6901 preston rd; plano TX 75024
• Manufacturer Contact: ronnie shalev ; 6901 preston road; plano, TX 75024 ; 9723098000
• MDR Report Key: 15983487
• MDR Text Key: 305491266
• Report Number: 1627487-2022-06813
• Device Sequence Number: 1
• Product Code: MHY
• UDI-Device Identifier: 05415067030016
• UDI-Public: 05415067030016
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P140009
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 04/06/2023

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
• Device Operator: Health Professional
• Device Expiration Date: 11/17/2018
• Device Model Number: 6660
• Device Catalogue Number: 6660
• Device Lot Number: 5731519
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 11/15/2022
• Initial Date FDA Received: 12/14/2022
• Supplement Dates Manufacturer Received: 03/21/2023
• Supplement Dates FDA Received: 04/06/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/17/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: DBS IPG (X1).; EXTENSIONS (X1).; EXTENSIONS (X1).; SCS ANCHOR (X1).; SCS ANCHOR (X1).; SCS LEAD (X1).
• Patient Outcome(s): Other
• Patient Sex: Female