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

Model Number 3608

Device Problem Communication or Transmission Problem (2896)

Patient Problem Inadequate Pain Relief (2388)

Event Type  Injury  

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.

Event Description

It was reported the patient's ipg would automatically increase when turned on and sometimes it would automatically power off (date of event unknown).Follow-up identified the sjm representative met with the patient and during that time he was unable to get the patient programmer to communicate with the ipg.Reportedly, a second patient programmer was tried to no avail.As a result, surgical intervention was undertaken during which time the original ipg was explanted and replaced with an updated model.The issue is resolved.

• 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: 5432031
• MDR Text Key: 38076794
• Report Number: 1627487-2016-00614
• Device Sequence Number: 1
• Product Code: GZB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P010032
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/21/2016

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?: No
• Device Operator: Health Professional
• Device Expiration Date: 06/28/2014
• Device Model Number: 3608
• Device Lot Number: 3737694
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 01/21/2016
• Initial Date FDA Received: 02/11/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/27/2012
• 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): Other