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

Model Number 97714

Device Problems Electromagnetic Interference (1194); Failure to Deliver Energy (1211); Device Operates Differently Than Expected (2913)

Patient Problem Therapeutic Effects, Unexpected (2099)

Event Date 12/29/2014

Event Type  malfunction  

Event Description

It was reported that she tried using her programmer to put it into mri mode but was not able to do so with following the instructions in the book.During the report, the patient was assisted to do so.The patient synced twice and was able to get to the therapy screen and turn her stimulator off by putting it in mri mode.It showed the patient was eligible for a full body mri.The patient was instructed as to how to turn the stimulator on, but she initially did not see the lightning bolt.She got the ¿lower limit reached¿ screen.The screen was cleared and the patient had to push the on button twice to confirm that therapy was on.The patient stated she felt no stimulation, ever since she had gotten out of the mri.The patient synced again and confirmed and was on the therapy screen.She synced yet again and then felt stimulation.The patient went through the steps again, but she had to push the on button twice to see the lightning bolt.The programmer appeared to be working.

Manufacturer Narrative

Concomitant medical products: product id: 97754, serial# (b)(4), product type: recharger.Product id: 97740, serial# (b)(4), product type: programmer, patient.Product id: 977a160, serial# (b)(4), implanted: (b)(6) 2014, product type: lead.Product id: 977a160, 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: 4428171
• MDR Text Key: 5170531
• Report Number: 3004209178-2015-00870
• 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: 12/29/2014

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: 12/14/2014
• Device Model Number: 97714
• Device Catalogue Number: 97714
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 12/29/2014
• Initial Date FDA Received: 01/16/2015
• Date Device Manufactured: 01/16/2014
• 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 Age: 00067 YR