MAUDE Adverse Event Report: ST. JUDE MEDICAL - NEUROMODULATION PENTA 3MM LEAD, 60 CM; SCS LEAD

Model Number 3228

Device Problems Disconnection (1171); Device Operates Differently Than Expected (2913); Unintended Movement (3026)

Patient Problem Inadequate Pain Relief (2388)

Event Date 11/15/2014

Event Type  Injury  

Event Description

Device 1 of 2.Reference mfr report: 1627487-2014-02865.It was reported the patient was complaining of ineffective stimulation therapy from his scs system.A sjm representative met with the patient and performed a system diagnostics, which showed low impedances for multiple lead contacts.Reprogramming was attempted but effective stimulation therapy could not be obtained for the patient.X-rays taken indicated the patient's scs lead had migrated.Surgical intervention was taken and the patient's lead was repositioned and anchored.Intra-operative testing still showed impedances were low.The physician opened the patient's ipg pocket and removed the lead tails from the ipg, and inspected the tails for any fluid intrusion.No fluid intrusion was observed.The physician attempted to reconnect the lead, but had difficulty seating the tails in the ipg.The lead tails were eventually secured in the ipg.Impedances tested within normal range and the patient reported receiving effective stimulation therapy postoperative.

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: PENTA 3MM LEAD, 60 CM
• Type of Device: SCS LEAD
• 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: 4334118
• MDR Text Key: 17265243
• Report Number: 1627487-2014-02864
• 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: 11/20/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/16/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Device Expiration Date: 05/28/2016
• Device Model Number: 3228
• Device Lot Number: 4607923
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/20/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/13/2014
• 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
• Patient Outcome(s): Other
• Patient Age: 42 YR