MAUDE Adverse Event Report: ST. JUDE MEDICAL - NEUROMODULATION INFINITY IPG; DBS IPG

Model Number 6662

Device Problem Application Program Freezes, Becomes Nonfunctional (4031)

Patient Problem Inadequate Pain Relief (2388)

Event Date 05/08/2019

Event Type  Injury  

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.

Event Description

It was reported that the patient experienced an inoperable ipg.The patient reported having a procedure in which monopolar electrocautery was used and surgery mode had not been enabled.The field representative was not able to connect to the ipg following the surgery.The patient may undergo surgical intervention.

Event Description

Follow up information received that the patient underwent surgery, where the ipg was explanted.

Event Description

Follow up information received that during surgery, the patient had the ipg replaced.Effective therapy was restored post operation.

Manufacturer Narrative

The reported allegation that the ipg could not communicate with the patient's controller was confirmed.The real-time status check using the uep showed the device¿s firmware was not running and had a stuck processor.Although the device was able to be successfully placed in the therapy application, it was never able to pair with a cp.Per the event details, the patient underwent an emergency surgical procedure in between stage one and stage two of patient's programming session and the device was not placed into surgery mode.The date of the surgery was not provided.The uep register confirmed the last valid daily battery logged was (b)(6) 2019.The device inhibits diagnostic logging once it enters the service application state.As the battery was not depleted, the only other reason for the device to stop logging the daily battery voltage was due to being in the service application state.The reset log also showed the device experienced multiple resets on (b)(6) 2019.This suggests the patients¿ surgery occurred in this time frame.The root cause of the issue is the device being exposed to an electrosurgery device.There is guidance noted in the clinicians manual concerning handling of the device: electro surgery devices should not be used in close proximity to an implanted neuro stimulation system.As a result of this finding, actions have been taken to prevent reoccurrence.

• Brand Name: INFINITY IPG
• Type of Device: DBS IPG
• Manufacturer (Section D): ST. JUDE MEDICAL - NEUROMODULATION; 6901 preston rd; plano TX 75024
• Manufacturer (Section G): ST. JUDE MEDICAL - NEUROMODULATION; 6901 preston rd; plano TX 75024
• Manufacturer Contact: andrea deitz ; 6901 preston road; plano, TX 75024 ; 9723098000
• MDR Report Key: 8631570
• MDR Text Key: 145760169
• Report Number: 1627487-2019-05984
• Device Sequence Number: 1
• Product Code: MHY
• UDI-Device Identifier: 05415067020260
• UDI-Public: 05415067020260
• 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,health
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 09/09/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/22/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 01/22/2021
• Device Model Number: 6662
• Device Lot Number: 6819694
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/17/2019
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/22/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/23/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: 1627487/06/02/2017/001-C
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Weight: 75