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

Model Number 6644

Device Problem Communication or Transmission Problem (2896)

Patient Problem Therapeutic Response, Decreased (2271)

Event Date 11/27/2014

Event Type  Injury  

Event Description

It was reported the patient (india) was unable to adjust stimulation with her programmer.An sjm representative met with the patient but was unable to establish communication between the patient's ipg and a replacement programmer.A communication error code was displayed.The patient's ipg was explanted and replaced during surgery on 04/04/2015.Effective stimulation was reportedly restored postoperative.

Manufacturer Narrative

This device is not approved for sale in the usa, but is similar to a usa marketed/approved device.Section d.2b (device product code) is only populated for esubmission purposes.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

Results: a visual inspection of the ipg did not reveal any discrepancies.Communication with the device during initial testing was unsuccessful when using a patient programmer and wdl utility.Electrical analysis confirmed capacitor c2 in the voltage regulation (vreg) circuit was leaking excessive current, which resulted in premature battery depletion and a sudden loss of stimulation and communication as observed in the field.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: SCS 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: 4725166
• MDR Text Key: 5748110
• Report Number: 1627487-2015-06171
• Device Sequence Number: 1
• Product Code: GZB
• Combination Product (y/n): N
• Reporter Country Code: IN
• 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
• Report Date: 06/02/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/28/2015
• Device Model Number: 6644
• Device Lot Number: 4160019
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/15/2015
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 06/02/2015
• Initial Date FDA Received: 04/23/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 06/26/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/15/2013
• 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
• Patient Outcome(s): Other