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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC MED REL MEDTRONIC PUERTO RICO PRIMEADVANCED STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF

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MEDTRONIC MED REL MEDTRONIC PUERTO RICO PRIMEADVANCED STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF Back to Search Results
Model Number 37702
Device Problems Electromagnetic Interference (1194); Battery Problem (2885)
Patient Problems Headache (1880); High Blood Pressure/ Hypertension (1908); Pain (1994); Dizziness (2194); Therapeutic Response, Decreased (2271); Complaint, Ill-Defined (2331)
Event Type  malfunction  
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
Information was received from a patient who was implanted with an implantable neurostimulator (ins) for other pain indications ¿ other. The patient reported that the doctor who implanted it wouldn¿t give her control of it and it stopped giving her any pain relief, so she just let the battery die. The patient didn¿t know what else to do. The patient reported that it was not turned on, the battery was dead. The patient reported that she accidentally went through a metal detector last saturday night and it made her feel very odd. The patient reported that her head was buzzing, she felt very dizzy, and her chest around the device hurt. The patient reported that she thought this was very strange because the battery was dead. The patient reported that she was at a concert and the emts hooked her up to a cardiac monitor and everything looked fine, just her blood pressure was a little high. The patient reported that she felt okay now, have just had a headache off and on since then. No further complications were reported.
 
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Brand NamePRIMEADVANCED
Type of DeviceSTIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF
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
lisa woodward clark
7000 central avenue ne rcw215
minneapolis, MN 55432
7635263920
MDR Report Key8261521
MDR Text Key133551576
Report Number3004209178-2019-01328
Device Sequence Number1
Product Code LGW
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
P840001
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer
Reporter Occupation
Type of Report Initial
Report Date 01/18/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received01/18/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date04/28/2008
Device Model Number37702
Device Catalogue Number37702
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received01/14/2019
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured11/09/2006
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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