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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC MED REL MEDTRONIC PUERTO RICO SOLETRA; STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR

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MEDTRONIC MED REL MEDTRONIC PUERTO RICO SOLETRA; STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR Back to Search Results
Model Number 7426
Device Problems Electromagnetic Interference (1194); Failure to Deliver Energy (1211)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Type  malfunction  
Manufacturer Narrative
The event date is unknown.If information is provided in the future, a supplemental report will be issued.
 
Event Description
It was reported they are trying to have an mri done, however, they had troubles in the past and are not sure what to do as the unit kept shutting off in the past.The end of 2019 or first year of 2020, the patient had another mri and the implantable neurostimulator (ins) would cut off when the patient got in the door.They had the hardest time getting the ins back on.When the patient laid flat on the table in hall and rolled in mri room, the ins did not cut off.They called the manufacturer that day and was told that could not be overturned with unit shutting off.It was advised the healthcare provider (hcp) call into technical services and the patient can check ins status as well.It was reviewed the reed switch is in the device.They were able to get the mri done and finish by having the patient lay on table and roll her in, in order to avoid having the ins shut off.They had to constantly turn back on as it kept turning off and on.It was reviewed this can occur because of reed switch.
 
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Brand Name
SOLETRA
Type of Device
STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR
Manufacturer (Section D)
MEDTRONIC MED REL MEDTRONIC PUERTO RICO
road 31, km. 24, hm 4
ceiba norte industrial park
juncos PR 00777
Manufacturer (Section G)
MEDTRONIC MED REL MEDTRONIC PUERTO RICO
road 31, km. 24, hm 4
ceiba norte industrial park
juncos PR 00777
Manufacturer Contact
david gustafson
7000 central avenue ne rcw215
minneapolis, MN 55432
7635149628
MDR Report Key10367522
MDR Text Key201738823
Report Number3004209178-2020-13465
Device Sequence Number1
Product Code MHY
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
P960009
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type other
Reporter Occupation Other
Type of Report Initial
Report Date 08/05/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date05/28/2012
Device Model Number7426
Device Catalogue Number7426
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 08/03/2020
Initial Date FDA Received08/05/2020
Date Device Manufactured11/29/2010
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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