MAUDE Adverse Event Report: ST. JUDE MEDICAL - NEUROMODULATION QUATTRODE LEAD WIDE SPACED, 60 CM; SCS LEAD

Model Number 3166

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

Patient Problem Seizures (2063)

Event Type  Injury  

Event Description

The patient has 4 leads with three lot numbers.Device 1 of 3.Reference mfr report #: 1627487-2015-07426 and 1627487-2015-07427.It was reported the patient experienced seizures.As a result, the patient will underwent surgical intervention.

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).

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 1 of 4.Reference mfr report #: 1627487-2015-07426, reference mfr report #: 1627487-2015-07427, reference mfr report #: 1627487-2015-10305.The patient has two leads (device 2) with the same lot number.The ipg is being added as device 4.A review of the patient's medical chart identified the patient's entire scs system was explanted on (b)(6) 2015.Additional retrospective review of the manufacturer's complaint database identified related events that were previously reported.On (b)(6) 2013, the patient reported he had stopped charging his ipg and was unable to communicate with his ipg using either his programmer or charger.Follow-up information identified the patient had been in an accident, suffered a seizure and lost his memory.The patient stated he would like to have his scs system explanted.(reference mfr.Report#: 1627487-2013-13444).On (b)(6) 2014, the patient reported he has not had stimulation and has not charged his ipg in a long time.In turn, the patient's ipg is inoperable.Additionally, the patient reported not receiving effective stimulation.Additional information received revealed the patient is allegedly experiencing swelling at the ipg site.Surgical intervention to explant the scs system is pending.(reference mfr.Report#: 1627487-2014-25292, 1627487-2014-25293, 1627487-2014-25294 and 1627487-2014-25295).

• Brand Name: QUATTRODE LEAD WIDE SPACED, 60 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: 4957083
• MDR Text Key: 6196321
• Report Number: 1627487-2015-07425
• 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,company representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 10/13/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/31/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 09/28/2012
• Device Model Number: 3166
• Device Lot Number: 3209001
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/13/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/21/2010
• 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: 3342 (X2), SCS EXTENSIONS
• Patient Outcome(s): Other