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

Model Number 3166

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

Patient Problems Pain (1994); Burning Sensation (2146); Weight Changes (2607)

Event Date 06/20/2017

Event Type  Injury  

Manufacturer Narrative

In the event the device is returned to the manufacturer, the reported event cannot be analyzed via laboratory testing.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 #2 of 3: reference mfr.Report: 1627487-2017-03753 and 1627487-2017-03755.The patient is implanted with 2 (model 3166) and 2 (model 3149) leads with same lot number.It was reported the patient has lost 70 pounds and thus the leads and ipg are now superficial to the skin which is causing discomfort at the ipg and lead sites.In addition the patient is experiencing discomfort described by the patient as heating (reference mfr.Report: 1627187-2017-03746).The patient is having to increase the level of stimulation to attain effective stimulation.Surgical intervention may be pending to address this issue.

Event Description

Device #2 of 3: reference mfr.Report: 1627487-2017-03753 and 1627487-2017-03755.Follow up information identified x-rays were ordered and results are pending.

• Brand Name: QUATTRODE LEAD WIDE SPACED, 60 CM
• Type of Device: PNS 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: 6711786
• MDR Text Key: 79969463
• Report Number: 1627487-2017-03754
• 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,health
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 08/24/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/13/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 06/28/2013
• Device Model Number: 3166
• Device Lot Number: 3416797
• Other Device ID Number: 0541473440166
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/31/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/14/2011
• 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 3346 (2), SCS EXTENSION
• Patient Outcome(s): Other
• Patient Age: 58 YR