MAUDE Adverse Event Report: ST. JUDE MEDICAL - NEUROMODULATION QUATTRODE LEAD, 3/4MM, 60 CM; SCS LEAD

Model Number 3146

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Skin Erosion (2075); Discomfort (2330)

Event Date 12/25/2014

Event Type  Injury  

Event Description

Device 1 of 2.Reference mfr report#1627487-2015-08053.The patient received two 3146 model leads with the same lot number.It was reported the lead eroded through the skin at the base of the dorsal incision site.Surgical intervention was undertaken, explanting the leads.Reportedly, an infection was not confirmed.

Event Description

Device 1 of 2.Reference mfr report#1627487-2015-08053.

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.

Manufacturer Narrative

Results: the complaint was not confirmed.As received, microscopic inspection revealed instrumentation damage on lead quattrode (3146) ¿a¿.This damage is consistent with leads being pulled while the setscrews were still engaged.The lead was returned with a missing terminal electrode for channel 1.The damaged electrode was consistent with the explant procedure.Quattrode (3146) ¿b¿ was returned complete.No functional testing was performed due to broken wires in lead ¿b¿.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: QUATTRODE LEAD, 3/4MM, 60 CM
• Type of Device: SCS LEAD
• Manufacturer (Section D): ST. JUDE MEDICAL - NEUROMODULATION; 6901 preston road; plano TX 75024
• Manufacturer (Section G): ST. JUDE MEDICAL - NEUROMODULATION; 6901 preston road; plano TX 75024
• MDR Report Key: 4508673
• MDR Text Key: 5528727
• Report Number: 1627487-2015-08052
• 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,Followup
• Report Date: 04/06/2015

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?: No
• Device Operator: Health Professional
• Device Expiration Date: 12/28/2014
• Device Model Number: 3146
• Device Lot Number: 3879973
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/19/2015
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 04/06/2015
• Initial Date FDA Received: 02/11/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 05/05/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/06/2012
• 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 3789, SCS IPG,; MODEL 3341(2), SCS EXTENSION,
• Patient Outcome(s): Other
• Patient Age: 27 YR