MAUDE Adverse Event Report: MEDTRONIC MED REL MEDTRONIC PUERTO RICO SURESCAN; STIMULATOR, SPINAL-CORD, IMPLANTED (PAIN RELIEF)

Model Number 97702

Device Problems Inappropriate/Inadequate Shock/Stimulation (1574); Device Operates Differently Than Expected (2913)

Patient Problems Tingling (2171); Discomfort (2330); Electric Shock (2554)

Event Type  malfunction  

Event Description

It was originally reported whenever the patient would place their hands above their head they would feel a tingling sensation.It was noted the feeling was not very comfortable.It was noted the feeling began when the device was implanted.It was further reported the patient had a second car accident.It was noted the patient had tingling in their front thigh which affected the right leg and foot.It was stated the stimulation was lower on the right leg than the left leg.It was noted 3 days prior to report the patient had changed a light in their basement and did not turn off the stimulation and thought they would ¿jump off the ladder for a minute or two.¿ it was stated the patient would leave the stimulation on when they were driving a mile but they would turn it off when they were driving a long distance.It was stated the patient would turn the stimulation off when going through the airport.It was stated the patient ¿never got shock where they would lose control.¿ it was noted the patient was doing well.The patient later reported on (b)(6) 2013 that when he sits down he can feel tingling in his thigh.When he raises his hands above his head it feels like ¿his finger is in a light socket¿.He has an appointment with his doctor after the (b)(6) of the year and will discuss then about the sensations he has felt with stimulation.It was noted that he does not have a managing doctor for his stimulation therapy.The patient was ¿generally satisfied¿ with the device therapy.He has decreased his oral medication of hydrocodone and valium by 50%.It was mentioned that he has had 5 back surgeries in 20 years.He has had 2 car accidents in 4 months.His back was broken in 3 places from the first accident and the second accident caused him to suffer from a pinched nerve at l5 and s1.His back has been fused in 3 different areas of his spine.The back problems started in 1984 and the ¿bottom 3¿ were fused in 1992.There are times that he will turn his stimulation off for 2-3 days if he does not need it.

Manufacturer Narrative

Concomitant medical products: product id: 97740, serial# (b)(4), product type: programmer, patient.Product id: 977a260, serial# (b)(4), implanted: (b)(6) 2013, product type: lead.Product id: 977a260, serial# (b)(4), implanted: (b)(6) 2013, product type: lead.(b)(4).

• Brand Name: SURESCAN
• Type of Device: STIMULATOR, SPINAL-CORD, IMPLANTED (PAIN RELIEF)
• Manufacturer (Section D): MEDTRONIC MED REL MEDTRONIC PUERTO RICO; ceiba norte industrial park, r; juncos PR 00777
• Manufacturer (Section G): MEDTRONIC NEUROMODULATION; 7000 central avenue ne rcw215; minneapolis MN 55432
• Manufacturer Contact: chad hedlund ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635149619
• MDR Report Key: 3556048
• MDR Text Key: 4052837
• Report Number: 3004209178-2014-00231
• Device Sequence Number: 1
• Product Code: GZB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P840001
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/20/2013

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/28/2014
• Device Model Number: 97702
• Device Catalogue Number: 97702
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 12/20/2013
• Initial Date FDA Received: 01/06/2014
• Date Device Manufactured: 05/30/2013
• 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 Age: 00066 YR