MAUDE Adverse Event Report: ST. JUDE MEDICAL - NEUROMODULATION PROTEGE IPG, 16-CHANNEL RECHARGEABLE; SCS IPG

Model Number 3789

Device Problem Unintended Movement (3026)

Patient Problem Pain (1994)

Event Date 02/18/2015

Event Type  Injury  

Event Description

It was reported the patient complained of pain at her scs ipg site.A sjm representative met with the patient and observed the patient's ipg appears to be angled.The header of the ipg is protruding and the ipg is superficial.The patient stated she feels like the ipg has moved and is not near the belt line.Surgical intervention is planned for a later date to address the issue.

Event Description

Follow-up identified surgical intervention was undertaken and the patient's scs ipg was relocated to a new pocket on the same side but lower and deeper.Additional follow-up identified the reported issue has been resolved.

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.

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.

• Brand Name: PROTEGE IPG, 16-CHANNEL RECHARGEABLE
• 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: 4638358
• MDR Text Key: 5618956
• Report Number: 1627487-2015-01110
• 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,Followup
• Report Date: 04/09/2015

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?: No
• Device Operator: Other
• Device Expiration Date: 09/28/2016
• Device Model Number: 3789
• Device Lot Number: 4772769
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 04/09/2015
• Initial Date FDA Received: 03/27/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 05/05/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/04/2014
• 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 (X2), SCS LEAD; MODEL 1192 (X2), SCS ANCHOR
• Patient Outcome(s): Other
• Patient Age: 60 YR