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 Loss of Range of Motion (2032); Inadequate Pain Relief (2388)

Event Date 05/26/2015

Event Type  Injury  

Event Description

It was reported the patient ((b)(6)) abruptly loss stimulation and experienced a sudden deterioration of mobility.Diagnostics revealed the patient's ipg was depleted.Additionally, it was noted by the physician that the patient's ipg depleted prematurely.Subsequently, the patient was hospitalized on (b)(6) 2015 and underwent surgical intervention on (b)(6) 2015 to explant and replace the ipg.Therapy was restored post-operative.

Manufacturer Narrative

(b)(4).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.

Manufacturer Narrative

Evaluation: results: a visual inspection of the ipg did not reveal any discrepancies.Communication with the device as received was unsuccessful when using a patient programmer and wdl utility.With the device attached to an external supply, it was subjected to a functional test on automated test equipment (ate).This tester verifies the electrical performance of the control/communication circuitry, and output signal integrity.All portions of ate testing passed.Based on the available information, the estimated longevity was 35 months.The device provided 31 months of stimulation at the time of the observation, and had exceeded 88% of the estimated longevity, which is beyond the minimum requirement of 75%.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; 6901 preston rd; plano TX 75024
• Manufacturer (Section G): ST. JUDE MEDICAL - NEUROMODULATION; 6901 preston rd; plano TX 75024
• MDR Report Key: 4860054
• MDR Text Key: 5872735
• Report Number: 1627487-2015-25111
• Device Sequence Number: 1
• Product Code: GZB
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: P010032
• 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: 06/23/2015

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: 08/28/2014
• Device Model Number: 6644
• Device Lot Number: 3776129
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/23/2015
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 06/23/2015
• Initial Date FDA Received: 06/22/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 07/14/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/13/2012
• 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
• Patient Outcome(s): Hospitalization
• Patient Age: 67 YR