MAUDE Adverse Event Report: ST. JUDE MEDICAL - NEUROMODULATION EXTENSION, DUAL 4 CHANNEL 10CM; SCS EXTENSION

Model Number 3341

Device Problems Pocket Stimulation (1463); Low impedance (2285)

Patient Problem Inadequate Pain Relief (2388)

Event Date 08/26/2016

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

Device 6 of 6: reference mfr report: 1627487-2016-05885, reference mfr report: 1627487-2016-05886, reference mfr report: 1627487-2016-05887, reference mfr report: 1627487-2016-05888, reference mfr report: 1627487-2016-05889.The patient has 2 extensions with the same lot number.It was reported the patient lost stimulation coverage in the targeted areas of neck and shoulders and is experiencing stimulation like sensation at the ipg pocket site.Diagnostics showed low impedances and x-rays indicate the peripheral leads have coiled around in the ipg pocket.Surgical intervention may be pending to address the 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.

Event Description

Device 6 of 6: reference mfr report: 1627487-2016-05889, reference mfr report: 1627487-2016-05888, reference mfr report: 1627487-2016-05887, reference mfr.Report 1627487-2016-05886, reference mfr.Report 1627487-2016-05885.Follow-up identified surgical intervention was undertaken during which time the entire scs system was explanted.

• Brand Name: EXTENSION, DUAL 4 CHANNEL 10CM
• 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: 6096979
• MDR Text Key: 59718771
• Report Number: 1627487-2016-05890
• 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: consumer
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 12/16/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/11/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2017
• Device Model Number: 3341
• Device Lot Number: 5311237
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/16/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/01/2015
• 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: 55 YR