MAUDE Adverse Event Report: ST. JUDE MEDICAL - NEUROMODULATION LIBRAXP PULSE GENERATOR, DUAL 4-CHANNEL; DBS IPG

Model Number 6644

Device Problem Premature End-of-Life Indicator (1480)

Patient Problem Inadequate Pain Relief (2388)

Event Date 11/19/2014

Event Type  Injury  

Event Description

Follow-up information indicated the patient is reportedly receiving effective stimulation coverage.

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.

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.

Manufacturer Narrative

This device is not approved for sale in the usa, but is similar to a usa marketed/approved device.Results: pulse load testing of the ipg with the original battery in circuit confirmed the ipg battery was at the end of life.Based on the provided information the device depleted before its estimated end of life.The complete programming history was unknown.The reason for the prematurely depleted battery was not ascertained.The device substrate electrically met specification.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

It was reported the patient (b)(6) received a low battery message due to possible premature battery depletion.The message was cleared, however it continued to reappear.Subsequently, the patient lost stimulation.Surgical intervention was undertaken and the ipg was explanted and replaced.Based on the program settings, the estimated longevity of the ipg is 111 months.Premature battery depletion is suspected.

Manufacturer Narrative

This device is not approved for sale in the usa, but is similar to a usa marketed/approved device.(b)(4).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.

• Brand Name: LIBRAXP PULSE GENERATOR, DUAL 4-CHANNEL
• Type of Device: DBS IPG
• Manufacturer (Section D): ST. JUDE MEDICAL - NEUROMODULATION; plano TX
• Manufacturer (Section G): ST. JUDE MEDICAL - NEUROMODULATION; 6901 preston rd; plano TX 75024
• MDR Report Key: 4345872
• MDR Text Key: 5284139
• Report Number: 1627487-2014-15887
• Device Sequence Number: 1
• Product Code: GZB
• Combination Product (y/n): N
• Reporter Country Code: AU
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 02/09/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/19/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/28/2014
• Device Model Number: 6644
• Device Lot Number: 3727444
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/26/2014
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/09/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/15/2012
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: MODEL 6147, DBS LEAD
• Patient Outcome(s): Other
• Patient Age: 61 YR