MAUDE Adverse Event Report: ST. JUDE MEDICAL - NEUROMODULATION QUATTRODE LEAD, 3/4MM, 90 CM; SCS LEAD

Model Number 3149

Device Problem High impedance (1291)

Patient Problems Fall (1848); Therapeutic Effects, Unexpected (2099); Inadequate Pain Relief (2388)

Event Date 09/13/2017

Event Type  Injury  

Manufacturer Narrative

The manufacturer 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.The manufacturer defers to the patient's physician regarding medical history.

Event Description

Device 4 of 4.Reference mfr.Report#: 1627487-2018-00933, reference mfr.Report#: 1627487-2018-00934, reference mfr.Report#: 1627487-2018-00935.The patient has an scs system for off-label use.It was reported the patient has been receiving inadequate therapy due to receiving stimulation in unintended areas after falling.An impedance check revealed high impedance on the patient's right occipital lead.As a result, the patient may undergo surgical intervention to address the issue.Note: all of the patient's leads are being reported because it is unknown which lead is liable.

Event Description

Device 4 of 4.Reference mfr.Report#: 1627487-2018-00933, reference mfr.Report#: 1627487-2018-00934, reference mfr.Report#: 1627487-2018-00935.Follow-up revealed the patient's leads were explanted and replaced.Surgical intervention resolved the patient's issue.

• Brand Name: QUATTRODE LEAD, 3/4MM, 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: 7229545
• MDR Text Key: 98625369
• Report Number: 1627487-2018-00936
• 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: 02/21/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/30/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/01/2009
• Device Model Number: 3149
• Device Lot Number: 65601
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/24/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/26/2007
• 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: 51 YR