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 06/11/2021

Event Type  Injury  

Event Description

It was reported that the ipg would not connect to the clinician programmer post implant.Service app mode, a safety mode enabled by the infinity ipg, was enabled.The clinician programmer displayed "cannot connect to generator.All appropriate trouble shooting steps were performed.Ipg was unable to be recovered and was deemed to be inoperable.The patient was thereby taken again to the operating room and the ipg was replaced with a new one.This addressed the issue.

Manufacturer Narrative

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 reported event for no ipg communication was confirmed.It was determined the device was running the service application software.This condition is consistent with electrocautery use during surgery.Per event details, the ipg no longer communicated following the ipg implant procedure.There is guidance in the clinicians manual regarding proper handling of the device when using electrocautery.As a result of this finding, actions have been taken to prevent reoccurrence.

• Brand Name: INFINITY 5 IMPLANTABLE PULSE GENERATOR
• Type of Device: DBS IPG
• Manufacturer (Section D): ABBOTT MEDICAL; 6901 preston rd; plano TX 75024
• MDR Report Key: 12083903
• MDR Text Key: 258889335
• Report Number: 1627487-2021-15199
• Device Sequence Number: 1
• Product Code: MHY
• UDI-Device Identifier: 05415067020246
• UDI-Public: 05415067020246
• Combination Product (y/n): N
• PMA/PMN Number: P14009
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 08/10/2021

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?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/06/2023
• Device Model Number: 6660
• Device Catalogue Number: 6660
• Device Lot Number: 7922989
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/17/2021
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 06/11/2021
• Initial Date FDA Received: 06/29/2021
• Supplement Dates Manufacturer Received: 08/09/2021
• Supplement Dates FDA Received: 08/10/2021
• 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
• Patient Weight: 61