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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 Intermittent Continuity (1121); Electromagnetic Interference (1194); Failure to Deliver Energy (1211)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 01/01/2008
Event Type  malfunction  
Manufacturer Narrative
The event date is an estimated date.If information is provided in the future, a supplemental report will be issued.
 
Event Description
It was reported that once or twice in 2008, when the patient had older implants, they had traveled under high power lines, which turned the implant off.No patient symptoms were reported.Refer to manufacturer report #3004209178-2020-21483 for related device.
 
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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 Key10976607
MDR Text Key220463838
Report Number3004209178-2020-21485
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 consumer
Reporter Occupation Non-Healthcare Professional
Type of Report Initial
Report Date 12/09/2020
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 Date01/28/2010
Device Model Number7426
Device Catalogue Number7426
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 12/08/2020
Initial Date FDA Received12/09/2020
Date Device Manufactured08/04/2008
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Age58 YR
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