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

Model Number 6660

Device Problem Wireless Communication Problem (3283)

Patient Problem Inadequate Pain Relief (2388)

Event Date 01/04/2022

Event Type  malfunction  

Manufacturer Narrative

During processing of this complaint, attempts were made to obtain weight but not received.

Event Description

Related manufacturer reference number 1627487-2022-00334.It was reported the patient underwent a non-related surgical procedure and it is not known if the ipg was placed into surgery mode prior to the procedure.As a result, the patient's ipg was unable to communicate with external devices and the patient lost therapy.A manufacturer representative confirmed the issue and the ipg was deemed inoperable.It is unknown which ipg is related to the issue.Therefore, all the suspected ipgs are being reported.No other information is available.

Manufacturer Narrative

Upon additional information received it was determined that, the issue should not have been submitted as a medical device report.

• Brand Name: INFINITY¿ 5 IMPLANTABLE PULSE GENERATOR
• Type of Device: DBS IPG
• 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: 13315390
• MDR Text Key: 284193114
• Report Number: 1627487-2022-00335
• Device Sequence Number: 1
• Product Code: MHY
• UDI-Device Identifier: 05415067020246
• UDI-Public: 05415067020246
• 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: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 02/10/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/21/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/05/2022
• Device Model Number: 6660
• Device Catalogue Number: 6660
• Device Lot Number: 7799888
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/04/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/14/2021
• 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 EXTENSION; DBS LEAD; DBS LEAD
• Patient Sex: Male