MAUDE Adverse Event Report: ST. JUDE MEDICAL - NEUROMODULATION SINGLE 8; SCS EXTENSION

Model Number 3386

Device Problem Arcing of Electrodes (2289)

Patient Problems Fall (1848); Inadequate Pain Relief (2388)

Event Date 06/19/2014

Event Type  Injury  

Event Description

Device 4 of 4.Reference mfr.Report#: 1627487-2014-23508, 1627487-2014-23517, 1627487-2014-23518.It was reported the patient is not receiving stimulation coverage after a recent fall.Diagnostic testing revealed high impedance readings on all lead contacts.Reprogramming was unable to resolve the issue.Follow-up information identified lead diagnostics are now showing multiple contacts with low impedance readings.X-rays did not reflect any anomalies.Surgical intervention is pending to address the reported issue.

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: SINGLE 8
• Type of Device: SCS EXTENSION
• Manufacturer (Section D): ST. JUDE MEDICAL - NEUROMODULATION; plano TX
• Manufacturer Contact: jennifer shepard ; 6901 preston rd.; plano, TX 75024 ; 9725264657
• MDR Report Key: 4009063
• MDR Text Key: 4951847
• Report Number: 1627487-2014-23519
• 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: 07/10/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/05/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/01/2013
• Device Model Number: 3386
• Device Lot Number: 3571617
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 07/10/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/01/2011
• 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
• Patient Age: 58 YR