MAUDE Adverse Event Report: ABBOTT MEDICAL INFINITY¿ 7 IMPLANTABLE PULSE GENERATOR; DBS IPG

Model Number 6662

Device Problem Battery Problem (2885)

Patient Problem Inadequate Pain Relief (2388)

Event Date 12/01/2022

Event Type  Injury  

Event Description

It was reported the patient¿s ipg approached end of life.Surgical intervention was undertaken on (b)(6) 2022 to address the issue.Ipg was explanted and replaced.Stimulation therapy was reportedly restored postoperatively.

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.(implant date unknown), unique device identifier (udi #): the udi is unknown because the lot number was not provide.

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¿ 7 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: 16062113
• MDR Text Key: 306276191
• Report Number: 1627487-2022-07103
• Device Sequence Number: 1
• Product Code: MHY
• 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: 12/30/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/28/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 6662
• Device Catalogue Number: 6662
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/28/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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: EXTENSIONS (X2); SCS LEAD (X2)
• Patient Outcome(s): Other
• Patient Age: 46 YR
• Patient Sex: Female
• Patient Weight: 91 KG