MAUDE Adverse Event Report: ST. JUDE MEDICAL - NEUROMODULATION QUATTRODE; SCS LEAD

Model Number 3166

Device Problems Self-Activation or Keying (1557); Device Operates Differently Than Expected (2913); Temperature Problem (3022)

Patient Problems Burning Sensation (2146); Inadequate Pain Relief (2388)

Event Date 04/01/2014

Event Type  Injury  

Event Description

Device 2 of 3.Reference mfr.Report #: 1627487-2014-26367, 26369.There are two lead from the same lot number and two leads from different lots for a total of 4 leads implanted.Patient was implanted with two pns leads (off-label) from the same lot number.It was reported the patient's ipg turned on by itself.The patient had to turn off the stimulation using the magnet.When the patient turned her stimulation back on only one side was providing effective stimulation.The patient reported she experienced a burning sensation at the lead site.Diagnostic testing showed that all contacts were valid.The patient has four programs but even with the amplitude maxed out she is only able to receive effective stimulation with one program.X-rays are pending.

Manufacturer Narrative

Sjm has limited info 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
• Type of Device: SCS LEAD
• Manufacturer (Section D): ST. JUDE MEDICAL - NEUROMODULATION; plano TX
• Manufacturer Contact: tanja hoffman ; 6901 preston rd.; plano, TX 75024 ; 9723098520
• MDR Report Key: 3799512
• MDR Text Key: 18300020
• Report Number: 1627487-2014-26368
• Device Sequence Number: 1
• Product Code: GZF
• 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: Not Applicable
• Type of Report: Initial
• Report Date: 04/08/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/30/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 10/01/2014
• Device Model Number: 3166
• Device Lot Number: 3831998
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/08/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/01/2012
• 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: IMPLANT DATE:; SCS EXTENSION: MODEL 3343 (2); IMPLANT DATE:; SCS IPG: MODEL 3788
• Patient Outcome(s): Other
• Patient Age: 28 YR