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

Model Number 6644

Device Problem Device Inoperable (1663)

Patient Problems Fall (1848); Inadequate Pain Relief (2388)

Event Type  Injury  

Manufacturer Narrative

(b)(4).This device is not approved for sale in the usa, but is similar to a usa marketed/approved device.(device product code) is only populated for e-submission 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.

Event Description

It was reported (b)(6) the patient lost stimulation following a fall.Troubleshooting was performed and revealed the ipg could not communicate with multiple external devices.X-rays were taken but the results are unknown.As a result, the patient will undergo surgical intervention.

• Brand Name: LIBRAXP PULSE GENERATOR, DUAL 4-CHANNEL
• 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: 5093777
• MDR Text Key: 26385653
• Report Number: 1627487-2015-07551
• Device Sequence Number: 1
• Product Code: GZB
• Combination Product (y/n): N
• Reporter Country Code: UK
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Report Date: 08/25/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/22/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 6644
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/25/2015
• 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
• Patient Sequence Number: 1
• Patient Outcome(s): Other