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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC EUROPE SARL PRIMEADVANCED STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR

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MEDTRONIC EUROPE SARL PRIMEADVANCED STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR Back to Search Results
Model Number 37702
Device Problems Intermittent Continuity (1121); Failure to Deliver Energy (1211); High impedance (1291); Patient Device Interaction Problem (4001)
Patient Problems Headache (1880); No Clinical Signs, Symptoms or Conditions (4582)
Event Date 04/03/2021
Event Type  Injury  
Manufacturer Narrative
Concomitant medical products: product id: 977a275, lot#: 0208226482, implanted: (b)(6) 2014. Product type: lead. Product id: 977a260, lot#: va1n95q010, implanted: (b)(6) 2018. Product type: lead. Other relevant device(s) are: product id: 977a275, serial/lot #: (b)(4), ubd: 02-apr-2018, udi#: (b)(4). Product id: 977a260, serial/lot #: (b)(4), ubd: 13-jan-2022, udi#: (b)(4). Event date is approximate. If information is provided in the future, a supplemental report will be issued.
 
Event Description
Information was received from a consumer, via a healthcare professional (hcp) and manufacturer representative (rep), regarding a patient with an implantable neurostimulator (ins) for hortons disease. It was reported there was a loss of therapy/loss of stimulation. The hcp had a session on jun-03 with the patient that said since a couple of months their right electrode has started to behave quite differently. The patient explained that there was some sort of sensations to begin with when they turn on the stimulation but it soon fades away regardless of them increasing the voltage. The stimulation on the left side works well in the way that the patient has strong sensations there but not quite like it used to be. Its more difficult for the patient to control the voltage even on the left side and its more sensitive to the patient changing position of their neck and head, like turning their head to one side or the other, but it is constant stimulation in contrast to the right side. The hcp checked the connection status to the ins and impedance on both electrode level and group level. The connection to pole 0 and pole 7 was marked with a red cross and impedance showed very high resistance on both those poles. Impedance on pole 0 was 11,178 ohm and on pole 7 over 25,000 ohm when testing with 3,0 v. The hcp noted that the strange thing was that pole 0  7 is for stimulation on the patient's left and pole 8  15 is for stimulation on the patient's right side; so the electrode that the patient has problems with is the electrode where all the connections were good and no high impedance. The hcp tried to change the poles for stimulation and pulse width to see if the patient could have persistent stimulation on their left side but it all went the same way and the patient felt the sensation but within seconds it faded out. Additional information was received from the manufacturer representative (rep). It was reported that the patient only experienced that the stimulation turns on and then fades away, there was no shocking or jolting sensations. Electrodes 0 and 7 were not used in the programmed electrodes but it was noted that the lead that causes the issues is the lead with excellent impedance; the lead with high impedance was for stimulation on the left side which was working. It was not known if the lead location had changed but the surgeon has entered an remittance for x-ray before surgery. The patient hasn't had any accident to their head and the problem with the right electrode has been a slow progress with slowly getting worsened.
 
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Brand NamePRIMEADVANCED
Type of DeviceSTIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR
Manufacturer (Section D)
MEDTRONIC EUROPE SARL
route du molliau 31
case postale
tolochenaz vaud 1131
SZ 1131
Manufacturer (Section G)
MEDTRONIC EUROPE SARL
route du molliau 31
case postale
tolochenaz vaud 1131
SZ 1131
Manufacturer Contact
david gustafson
7000 central avenue ne rcw215
minneapolis, MN 55432
7635149628
MDR Report Key11971199
MDR Text Key255389300
Report Number9614453-2021-02400
Device Sequence Number1
Product Code LGW
Combination Product (y/n)N
Reporter Country CodeSW
PMA/PMN Number
P840001
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,consum
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 06/25/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/09/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date09/28/2015
Device Model Number37702
Device Catalogue Number37702
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/18/2021
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured04/01/2014
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 06/09/2021 Patient Sequence Number: 1
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