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

Model Number 97714

Device Problem Device Operates Differently Than Expected (2913)

Patient Problems Muscle Spasm(s) (1966); Tingling (2171)

Event Type  Injury  

Event Description

It was reported that two months prior to the report the patient had been having really bad pain, her stimulation hadn¿t been working for her back, and she had a loss of therapeutic effect.The patient could still feel tingling in her legs.It was reported that the patient had a big knot in her back for the past two months, and wasn¿t sure if the leads came out or what was going on.A request was made to meet with the manufacturer¿s representative (rep) for reprogramming.Additional information received from the healthcare provider (hcp) stated that the patient still needed to be evaluated by the rep.At the time of the report to determine the cause of the event and if it was device related.No troubleshooting had been performed; it was unknown if there was a 50% or greater symptom reduction and it was unknown if the patient experienced a loss of stimulation.It was noted that the device was implanted for radiculopathy and was never intended for back coverage.No interventions or outcome were reported regarding this event.Additional information was received that stated the patient was going to have an mri done and needed to find out how to put the machine on mri status.The patient did not have the patient programmer (pp) with her and she did not have a date for the mri.It was explained to have the mri facility call so guidelines could be faxed and patient could call back to go over steps.It was noted the mri was related to her device therapy for her back.Therapy had been o.K.For a couple of months then she started having problems and had a loss of therapeutic effect.The patient met with the manufacturer¿s representative (rep) a couple of weeks ago, and the ¿machine¿ was adjusted and after that she started having real bad back spasms.The rep.Told the patient to turn the device off and make an appointment to see the healthcare provider (hcp).A ct scan was performed which did not tell them anything so they wanted to do an mri.The patient said they may want to take it out.It was further clarified that the mri the patient needs is of her back.The device was not working for her and she was going to get it taken out.The device only worked for a couple weeks after implant.The mri facility said the patient was not eligible for an mri.Additional information has been requested to find out the outcome of this event.If additional information is received, a follow up will be sent.

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: 977a260, serial# (b)(4), implanted: (b)(6) 2014, product type: lead.Product id: 977a260, serial# (b)(4), implanted: (b)(6) 2014, 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: diane wolf ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635263987
• MDR Report Key: 4240424
• MDR Text Key: 5072357
• Report Number: 3004209178-2014-21220
• 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,Health Professional
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 10/20/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/10/2014
• 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: 97714
• Device Catalogue Number: 97714
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/20/2014
• Date Device Manufactured: 01/09/2014
• 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: 00042 YR