MAUDE Adverse Event Report: ST. JUDE MEDICAL - NEUROMODULATION INFINITY 5; DBS IPG

Model Number 6660

Device Problem Device Inoperable (1663)

Patient Problem Inadequate Pain Relief (2388)

Event Date 12/02/2016

Event Type  Injury  

Manufacturer Narrative

The capa was initiated on (b)(6) 2016 to address the issue in which the ipg experienced loss of power, causing the patient to lose pain relief requiring replacement of the device.Investigation is currently in progress.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 has two dbs systems implanted.This report is for the left dbs ipg.Reference mfr report: 1627487-2017-01895 for right dbs ipg.It was reported the left dbs ipg was unable to communicate with the clinician programmer and was inoperable during the implant procedure on (b)(6 ) 2016.The ipg was removed and replaced during the procedure and issue was resolved.

Manufacturer Narrative

Brand name corrected.

• Brand Name: INFINITY 5
• 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: 6486144
• MDR Text Key: 72562728
• Report Number: 1627487-2017-01893
• 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: company representative
• Reporter Occupation: Other
• Remedial Action: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 06/28/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/12/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/29/2018
• Device Model Number: 6660
• Device Lot Number: 5553915
• Other Device ID Number: 05415067020246
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/27/2017
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/02/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/29/2016
• 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
• Patient Outcome(s): Other
• Patient Age: 59 YR