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

Model Number 97714

Device Problems Device Operates Differently Than Expected (2913); Material Deformation (2976)

Patient Problems Inflammation (1932); Pain (1994); Swelling (2091); Discomfort (2330)

Event Type  Injury  

Event Description

The patient needed to be reprogrammed, something about the therapy was not quite right and requires adjustment.The patient¿s ¿machine has already been programmed¿.The new implant was done on (b)(6) 2014, "a week later they turned it on".About 6 days after that the patient had it manipulated a little bit because when they turned it on, it changed which was to be expected.Then a month after they put it in, they actually put it so it was positional, up and down.So when you are standing and when you are lying down it will actually turn off or lower the voltage.The patient was trying to make an appointment for that.The patient has "spent a lot on this machine and i am expecting a lot to be done and all i want to do is get it programmed".The patient was programmed "last week".It was reported 3 weeks later that the stimulation was turning off.The stimulation was shutting off when the patient lifted her arms.This was noticed on (b)(6) 2014.The stimulation would change, lower or higher, depending on what the patient did with her arms.The patient was in a great amount of pain after the surgery and was told to wear a back brace until (b)(6) 2014.Near the patient¿s scapula has been inflamed "the whole time" since implant.The patient thought the lead was kinked or that something was wrong or shorted.It was noted that the patient¿s appointment scheduled for (b)(6) 2014 with her health care provider (hcp) and company representative was cancelled.The next day the patient reported that 2 weeks after she was implanted, she noticed every time she moved her arm it was painful.At first the patient thought it was a normal pain after surgery but the pain was getting worse.The patient went back to work about 3 weeks after she was implanted.The ins does not work and shuts off whenever the patient lifts her arms.The patient¿s back was extremely swollen.The patient wondered if it may be the wire.It kept rubbing in the muscle.It was noted that the patient was having a difficult time getting an appointment to see her doctor to get the pain and device diagnosed and to have the device reprogrammed.Three days later it was confirmed that the patient has an appointment on (b)(6).Several days later intermittent stimulation was reported.The stimulation would turn off when the patient lifted her arms up and then would turn on when she would put her arms back down.It would take 20 seconds for the stimulation to turn back on.Impedance testing was within normal limits at 1200 ohms.The patient reported coverage of pain with stimulation.Since the surgery the patient has a new pain causing most of her discomfort, which was addressed with an epidural injection with the doctor.The pain was at the midline incision site from surgery.Device reprogramming was performed.The patient outcome was alive with no injury.The cause of the event was unknown.No interventions were planned.The patient reported good stimulation coverage at her appointment.There were no further needs from a company representative at this point.

Manufacturer Narrative

Concomitant medical products: product id: 97740, serial# (b)(4), product type programmer, patient; product id: 97754, serial# (b)(4), product type: recharger; product id: 977a275, serial# (b)(4), implanted: (b)(6) 2014, product type: lead (x2); product id: 977a275, serial# (b)(4), implanted: (b)(6) 2014, product type: lead (x2).(b)(4).

Event Description

Additional information received from the healthcare provider (hcp) reported on (b)(6) 2014 stimulation was initiated.On (b)(6) 2014 the sensor portion was activated.

• 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: diane wolf ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635263987
• MDR Report Key: 3891976
• MDR Text Key: 4673027
• Report Number: 3004209178-2014-11975
• 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,Company Representative,company representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 06/02/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/24/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/14/2014
• Device Model Number: 97714
• Device Catalogue Number: 97714
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/25/2015
• Date Device Manufactured: 01/17/2014
• 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): Required Intervention
• Patient Age: 00049 YR