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 03/12/2021

Event Type  Injury  

Event Description

It was reported that the patient's ipg was inoperable following a patient procedure.Reportedly, the ipg was placed into surgery mode prior to the procedure, but was unresponsive following the procedure.As a result, the ipg was explanted and replaced.Surgical intervention resolved the issue.

Manufacturer Narrative

Correction, product information has been updated.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.

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 inoperable ipg 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 a lead revision 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: 11602241
• MDR Text Key: 243350775
• Report Number: 1627487-2021-12819
• Device Sequence Number: 1
• Product Code: MHY
• UDI-Device Identifier: 05415067020246
• UDI-Public: 05415067020246
• 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,health
• Remedial Action: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 05/17/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/01/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2021
• Device Model Number: 6660
• Device Catalogue Number: 6660
• Device Lot Number: 6835807
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/09/2021
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/14/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: 1627487/06022017/001/C
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 48 YR
• Patient Weight: 95