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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 Therapy Delivered to Incorrect Body Area (1508); Inappropriate/Inadequate Shock/Stimulation (1574)
Patient Problems Nausea (1970); Undesired Nerve Stimulation (1980); Therapeutic Effects, Unexpected (2099); Tingling (2171); Malaise (2359); Electric Shock (2554)
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 implanted with an implantable neurostimulator (ins) for cervical/neck. It was reported that the patient wanted to have his ins removed because it was not helping him and the patient thought the ins was making him sick. The patient was sick all the time; his stomach was always upset. The patient had been to healthcare professionals and they could not find what was wrong with him, nobody knew. The patient was to follow-up with a healthcare professional, but did not have a managing healthcare professional. The issues began years prior to (b)(6) 2016, the patient didn¿t know the exact year. Additional information received from the patient reported that when they would turn stimulation on, it would go into their arms instead of where the pain was, and it would be more of a tingling feeling. The patient stated that the sickness feeling hasn¿t yet been resolved. It was noted that the patient visited their healthcare provider (hcp) and an ultrasound was performed. The ultrasound revealed a grayish white gallbladder. The patient was told that it was bad and didn¿t look normal, and that they needed it taken out. The patient¿s gallbladder was removed in (b)(6) 2016. It was noted that the patient had previous ultrasounds where the hcp was unable to find anything. It was reported that the patient¿s sickness feeling never went away and that they thought it was because of the gallbladder, but they were still sick 24/7. The patient stated that the sickness feeling would even be present when eating and wouldn¿t allow them to feel full. It was further reported that the patient¿s stimulation was off all the time as it wasn¿t helping them. The patient stated that the stimulation was ¿just like electricity¿ going down the arms. The patient was to follow up with a hcp and was provided with physician listings.
 
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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
ceiba norte industrial park, r
juncos PR 00777
Manufacturer (Section G)
MEDTRONIC MED REL MEDTRONIC PUERTO RICO
ceiba norte industrial park, r
juncos PR 00777
Manufacturer Contact
diane wolf
7000 central avenue ne rcw215
minneapolis, MN 55432
7635263987
MDR Report Key6180834
MDR Text Key102065730
Report Number3004209178-2016-26617
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,Followup
Report Date 12/16/2016
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/16/2016
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date08/28/2010
Device Model Number37702
Device Catalogue Number37702
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received11/30/2016
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured03/13/2009
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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