MAUDE Adverse Event Report: ST. JUDE MEDICAL - NEUROMODULATION IMPLANTABLE NEUROSTIMULATOR KIT; DRG IPG

Model Number MN10200

Device Problem Application Program Freezes, Becomes Nonfunctional (4031)

Patient Problem Inadequate Pain Relief (2388)

Event Date 03/04/2019

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.The results/method and conclusion codes along with investigation results will be provided in the final report.

Event Description

It was reported the patient underwent an unrelated surgical procedure (date unknown).Since the procedure, the patient's ipg has been unable to communicate with their external device due to it being inoperable.Troubleshooting attempts have been unable to provide resolution.As a result, the patient's ipg was explanted and replaced.Surgical intervention resolved the patient's issue.

Manufacturer Narrative

This device was incorrectly included in the service application fsca.

• Brand Name: IMPLANTABLE NEUROSTIMULATOR KIT
• Type of Device: DRG 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: 8702014
• MDR Text Key: 148133915
• Report Number: 1627487-2019-06963
• Device Sequence Number: 1
• Product Code: PMP
• UDI-Device Identifier: 05415067025500
• UDI-Public: 05415067025500
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P150004
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,consum
• Reporter Occupation: Physician
• Remedial Action: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 06/27/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/14/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 02/21/2019
• Device Model Number: MN10200
• Device Catalogue Number: MN10200
• Device Lot Number: DB7093
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/26/2019
• 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
• Removal/Correction Number: 1627487-06022017-001-C
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Weight: 59