MAUDE Adverse Event Report: MEDTRONIC MED REL MEDTRONIC PUERTO RICO INTERSTIM II; STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE

Model Number 3058

Device Problems Electromagnetic Interference (1194); Device Operates Differently Than Expected (2913); Compatibility Problem (2960); Noise, Audible (3273)

Patient Problems Pain (1994); Complaint, Ill-Defined (2331)

Event Type  malfunction  

Event Description

It was reported that a patient had an mri in june, she forgot to turn off the device, she didn¿t have the patient programmer to turn it off, and she thought it popped a couple of times and probably sparked.The reason for the mri was unrelated to the device.There were problems during the mri scan and they had to stop.The patient thought the machine was the worst machine, the magnetic resonance was too strong, and the bolts on her jeans were shaking and her rings were jittering during the calibration test.It was a very violent experience and the patient was told that she shouldn¿t have had that reaction, even with the device on.The patient was also told that the reaction would have occurred anyway even if she had turned the device off.The patient had pain at the implant side and in the lower back where the leads were, and since the mri the pain had gotten worse.She didn¿t know if the pain was related to her arthritis with the season change, she already had lower back pain, and she didn¿t know if the pain was because, there was something new in her body.The patient thought she may have hurt herself during the mri.In april, the patient had prolotherapy done to help with the pain, which did help but now the pain was back.She thought the mri had something to do with it because, she left the device on.The patient tried turning the device off for a few days and turning the power down.The device was off for almost two weeks, she turned it on and was able to go a few days where it didn¿t hurt and then it started hurting where the leads were, not where the implantable neurostimulator (ins) was.No interventions or outcome were reported regarding this event.Further follow-up is being conducted to obtain additional information.If additional information is received, a follow-up report will be sent.

Manufacturer Narrative

Product id 3093-28, lot# va087sr, implanted: 2013 (b)(6); product type lead product id 3093-28, lot# va087sr, implanted: 2013 (b)(6); product type lead.(b)(4).

• Brand Name: INTERSTIM II
• Type of Device: STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE
• 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: 4148460
• MDR Text Key: 4786525
• Report Number: 3004209178-2014-18435
• Device Sequence Number: 1
• Product Code: EZW
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P970004
• 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: 09/16/2014

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: 07/28/2014
• Device Model Number: 3058
• Device Catalogue Number: 3058
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 09/16/2014
• Initial Date FDA Received: 10/07/2014
• Date Device Manufactured: 02/08/2013
• 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: 00048 YR