MAUDE Adverse Event Report: ST. JUDE MEDICAL - NEUROMODULATION IMEON MINI; SCS IPG

Model Number 3788

Device Problems Device Remains Activated (1525); Device Stops Intermittently (1599)

Patient Problem Inadequate Pain Relief (2388)

Event Date 06/30/2014

Event Type  Injury  

Event Description

It was reported the pt thinks his pns system (off-label) is turning off and on by itself.The pt recharges every other day.F/u info identified the pt is not receiving stimulation now that his pns leads have healed into place.Lead diagnostics showed no anomalies.Surgical intervention may be pending to address this issue.

Manufacturer Narrative

Sjm has limited info related to the pt's medical history and is unable to form an opinion as to the relevancy of the pt's history to the event reported.Sjm defers to the pt's physician regarding medical history.

• Brand Name: IMEON MINI
• Type of Device: SCS IPG
• Manufacturer (Section D): ST. JUDE MEDICAL - NEUROMODULATION; plano TX
• Manufacturer Contact: tanja hoffman ; 6901 preston rd.; plano, TX 75024 ; 9723098520
• MDR Report Key: 4098851
• MDR Text Key: 4756532
• Report Number: 1627487-2014-26734
• 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: Not Applicable
• Type of Report: Initial
• Report Date: 08/22/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/11/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 01/01/2016
• Device Model Number: 3788
• Device Lot Number: 4405770
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/22/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/01/2014
• 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: IMPLANT DATE:; SCS LEAD: MODEL 3186 (2); IMPLANT DATE:; SCS ANCHOR: MODEL 1194 (2)
• Patient Outcome(s): Other
• Patient Age: 43 YR