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

Model Number 3608

Device Problem Difficult to Remove (1528)

Patient Problem Inadequate Pain Relief (2388)

Event Date 02/18/2016

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

Device 3 of 3.Reference mfr.Report #: 1627487-2016-01235, reference mfr.Report #: 1627487-2016-01237.It was reported the patient (b)(6) lost stimulation.Diagnostics testing revealed high impedance measurements.In turn, surgical intervention was undertaken.During the procedure the physician experienced difficulty removing the lead and used an epiducer to successfully explant and replace the lead.Further intra-op testing revealed high impedance measurements with the patient's extension.Subsequently, the patient's extension was explanted and replaced.It was noted the physician was unable to pull the extension out of the ipg header.As a result, the physician cut the extensions and explanted and replaced the ipg.Effective therapy was restored post-operative.The manufacturer is in the process of obtaining the patient's implant date.Concomitant product(s): the implant date for the following device is unknown: model: 1192, scs anchor.

Event Description

Device 3 of 3.Reference mfr.Report #: 1627487-2016-01235.Reference mfr.Report #: 1627487-2016-01237.

Event Description

Device 3 of 3.Reference mfr.Report #: 1627487-2016-01235.Reference mfr.Report #: 1627487-2016-01237.

Manufacturer Narrative

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

Device 3 of 3: reference mfr.Report #: 1627487-2016-01235, reference mfr.Report #: 1627487-2016-01237.

• 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: 5494881
• MDR Text Key: 40145972
• Report Number: 1627487-2016-01238
• 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: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 08/02/2016

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?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/28/2015
• Device Model Number: 3608
• Device Lot Number: 4028524
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/26/2016
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 02/18/2016
• Initial Date FDA Received: 03/11/2016
• Supplement Dates Manufacturer Received: Not provided; Not provided; Not provided
• Supplement Dates FDA Received: 04/12/2016; 06/16/2016; 08/23/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/09/2013
• 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