MAUDE Adverse Event Report: ST. JUDE MEDICAL - NEUROMODULATION EXTENSION, 30CM; SCS EXTENSION

Model Number 3383

Device Problem Low impedance (2285)

Patient Problems Therapeutic Effects, Unexpected (2099); Inadequate Pain Relief (2388)

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.(b)(4).

Event Description

The patient had two extensions from the same lot.Device 2 of 2.Reference mfr report #: 1627487-2016-06514 it was reported the patient experienced stimulation turning off by itself.An impedance check revealed low impedance on multiple contacts.Troubleshooting was attempted but could not provide resolution.As a result, the ipg and extensions were explanted and replaced on (b)(6) 2016.The issue was resolved.

• Brand Name: EXTENSION, 30CM
• Type of Device: SCS EXTENSION
• 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: 6191480
• MDR Text Key: 62907611
• Report Number: 1627487-2016-06516
• 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: 12/09/2016

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: 11/28/2013
• Device Model Number: 3383
• Device Lot Number: 3547100
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 12/09/2016
• Initial Date FDA Received: 12/20/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/15/2011
• 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
• Treatment: MODEL: 3228, SCS LEAD
• Patient Outcome(s): Other