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

Model Number 6662

Device Problem Device Inoperable (1663)

Patient Problem Inadequate Pain Relief (2388)

Event Type  Injury  

Manufacturer Narrative

Sjm has limited information related to the patient's medical history and is unable to form an opinion as to the relevancy of the patient's history to the event reported.Sjm defers to the patient's physician regarding medical history.

Event Description

The patient reports after undergoing a surgical procedure on (b)(6) 2017, the ipg was unable to communicate with the patient controller.The sjm representative was unable to resolve the issue.It was determined the ipg was inoperable.The patient underwent surgical intervention on (b)(6) 2017 where the ipg was removed and replaced.

Event Description

Follow up information identiified the issue was resolved.

Manufacturer Narrative

The capa was initiated on 2016-02-23 to address the issue of the proclaim ipg entering service application (orion ipg family).Investigation is complete and being monitored by the manufacturer.

• 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
• MDR Report Key: 6447140
• MDR Text Key: 71294511
• Report Number: 1627487-2017-01642
• Device Sequence Number: 1
• Product Code: MHY
• 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: consumer
• Reporter Occupation: Other
• Remedial Action: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 06/29/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/30/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/25/2018
• Device Model Number: 6662
• Device Lot Number: 5678888
• Other Device ID Number: 05415067020260
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/02/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/25/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: 1627487-060217-001-C
• Patient Sequence Number: 1
• Treatment: MODEL 6145, DBS LEAD
• Patient Outcome(s): Other