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

Model Number 6662

Device Problem Wireless Communication Problem (3283)

Patient Problem Inadequate Pain Relief (2388)

Event Date 06/18/2021

Event Type  Injury  

Manufacturer Narrative

Date of event is estimated.The device is included in the neuromodulation implantable pulse generator (ipg) inoperable when exposed to monopolar electrosurgery advisory notice issued by abbott on 02 june 2017.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 following magnetic resonance imaging (mri) where the device was not properly placed into mri mode, the ipg became unable to communicate with external devices.Troubleshooting was unable to resolve the issue.Surgical intervention took place wherein the ipg was explanted and replaced.Effective therapy was established.

Manufacturer Narrative

The reported observation of ¿cannot connect to generator¿ was confirmed.The analysis results concluded the inability to establish communication between the programmer and the implantable pulse generator (ipg) was due to the device entering the service application state.The root cause of the device entering the service application state was due to the patient¿s procedure.Clinician manual, arten600090483 mri procedure information, contains information regarding potential adverse events that may affect the operation of the ipg.

• Brand Name: INFINITY 7 IMPLANTABLE PULSE GENERATOR
• Type of Device: INFINITY IPG
• Manufacturer (Section D): ABBOTT MEDICAL; 6901 preston rd; plano TX 75024
• MDR Report Key: 12128228
• MDR Text Key: 260258440
• Report Number: 1627487-2021-15292
• Device Sequence Number: 1
• Product Code: MHY
• UDI-Device Identifier: 05415067030023
• UDI-Public: 05415067030023
• Combination Product (y/n): N
• PMA/PMN Number: P140009
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,consum
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 09/19/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/07/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 07/30/2022
• Device Model Number: 6662
• Device Catalogue Number: 6662
• Device Lot Number: 7602810
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/28/2021
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/10/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: 1627487/06/02/2017/001-C
• Patient Sequence Number: 1
• Patient Outcome(s): Other