MAUDE Adverse Event Report: ST. JUDE MEDICAL - NEUROMODULATION GENESIS PULSE GENERATOR, 8-CHANNEL; SCS IPG

Model Number 3608

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

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  Injury  

Manufacturer Narrative

Results: pulse load testing determined the device battery is depleted to the end of life.An accurate longevity could not be performed as the programming history and lead impedance history was unknown.The observation of an ipg low battery message was confirmed.The device functioned within specification throughout analysis.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 warning due to possible premature battery depletion, however, the patient did not lose stimulation.Surgical intervention was undertaken and the ipg was explanted and replaced.The patient reported effective stimulation coverage postoperative.

Manufacturer Narrative

(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: GENESIS PULSE GENERATOR, 8-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: 4578092
• MDR Text Key: 13454308
• Report Number: 1627487-2015-15078
• Device Sequence Number: 1
• Product Code: GZB
• Combination Product (y/n): N
• Reporter Country Code: SW
• 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: 04/28/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/06/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/28/2014
• Device Model Number: 3608
• Device Lot Number: 3806973
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/26/2015
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/28/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/18/2012
• 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 3186, SCS LEAD
• Patient Outcome(s): Other
• Patient Age: 75 YR
• Patient Weight: 60