MAUDE Adverse Event Report: MEDTRONIC NEUROMODULATION RESTORE ULTRA; STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF

Model Number 37712

Device Problem Energy Output To Patient Tissue Incorrect (1209)

Patient Problems Dysphagia/ Odynophagia (1815); Nausea (1970); Undesired Nerve Stimulation (1980)

Event Date 06/01/2018

Event Type  malfunction  

Manufacturer Narrative

Concomitant medical products: product id: 37712, serial# (b)(4), implanted: (b)(6) 2012, product type: implantable, neurostimulator.If information is provided in the future, a supplemental report will be issued.

Event Description

Information was received from a consumer with two implantable neurostimulators (ins) for other chronic/intract pain (trunk/limbs), o ther upper quadrant sites, and spinal pain.It was reported even though she has turned her devices off, the patient is still feeling stimulation and she can't get it to stop.The patient states she has already turned stim off on both ins's.The patient states she does experience residual stim for about 24 hours after turning stim off but this time it's different.The patient states it won't go away and it's making her sick.Patient reported residual stim and nausea.Communication with the patient programmer showed the ins was off.The patient was redirected to their healthcare provider to have the device checked.The patient stated that she has been trying to take medicine but can¿t because it won¿t go down.It feels like something is stuck in her throat.No further complications were reported/anticipated.Omitted information related to (b)(4) ¿ lead in wrong location.

• Brand Name: RESTORE ULTRA
• Type of Device: STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF
• Manufacturer (Section D): MEDTRONIC NEUROMODULATION; 800 53rd ave ne; minneapolis MN 55421 1200
• Manufacturer (Section G): MEDTRONIC NEUROMODULATION; 800 53rd ave ne; minneapolis MN 55421 1200
• Manufacturer Contact: lisa woodward clark ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635263920
• MDR Report Key: 7614472
• MDR Text Key: 112348123
• Report Number: 3007566237-2018-01824
• Device Sequence Number: 1
• Product Code: LGW
• 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: 06/19/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/19/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 37712
• Device Catalogue Number: 37712
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/14/2018
• 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: 71 YR