MAUDE Adverse Event Report: ST. JUDE MEDICAL - NEUROMODULATION QUATTRODE LEAD WIDE SPACED, 90 CM; SCS LEAD

Model Number 3169

Device Problems Fluid/Blood Leak (1250); Fracture (1260); Impedance Problem (2950)

Patient Problem Inadequate Pain Relief (2388)

Event Date 12/03/2015

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.Udi (di): (b)(4).

Event Description

The patient has an scs system for off-label use.It was reported the patient's lead had invalid impedance on multiple contacts.Fluid invasion and fracture was noted.As a result, the patient's lead was explanted and replaced on (b)(6) 2015.The issue was resolved by surgical intervention.

Manufacturer Narrative

Follow-up revealed the surgery date was (b)(6) 2015 not (b)(6) 2015.

• Brand Name: QUATTRODE LEAD WIDE SPACED, 90 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: 5332542
• MDR Text Key: 34597249
• Report Number: 1627487-2015-07733
• Device Sequence Number: 1
• Product Code: GZB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K072462
• 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: 12/30/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/29/2015
• 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: 3169
• Device Lot Number: 3546969
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/30/2015
• 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: 3166 (X2), SCS LEADS
• Patient Outcome(s): Other
• Patient Age: 51 YR