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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC PUERTO RICO OPERATIONS CO. RESTORESENSOR MRI STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF

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MEDTRONIC PUERTO RICO OPERATIONS CO. RESTORESENSOR MRI STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF Back to Search Results
Model Number 97714
Device Problems Break (1069); Failure to Deliver Energy (1211); High impedance (1291); Low impedance (2285); Delayed Charge Time (2586); Battery Problem (2885); Charging Problem (2892); Therapeutic or Diagnostic Output Failure (3023); Insufficient Information (3190); Patient Device Interaction Problem (4001)
Patient Problems Headache (1880); Therapeutic Effects, Unexpected (2099); Sleep Dysfunction (2517)
Event Date 09/03/2020
Event Type  malfunction  
Manufacturer Narrative
Concomitant medical products: product id: 3708160, serial#: (b)(4), product type: extension. Product id: 3708160, serial# (b)(4), product type: extension. Product id: 3778-60, serial# (b)(4), product type: lead product id: 3778-60, serial# (b)(4), product type: lead. If information is provided in the future, a supplemental report will be issued.
 
Event Description
It was reported the patient visited her physician on (b)(6) 2020 for a programming adjustment due to migraine pain. It was further reported the patient had previously visited the physician on (b)(6) 2020 for an adjustment for her migraine and on (b)(6) 2020 for an additional adjustment because the ¿program was not covering well. ¿ ¿an alert popped¿ when the patient¿s implantable neurostimulator (ins) was interrogated during the (b)(6) 2020 visit. Impedance testing was performed and found the patient had ¿open circuits involving electrodes 8 and 12;¿ contacts 8 and 12 were out of range (oor). The impedance testing results indicated both electrode 8 and 12 had impedances of >10000 ohms for all electrode pairs during the test. These electrodes were taken out of the patient¿s programming during the session. Following the reprogramming session, the patient reported the ins was ¿taking an extremely long-time charge¿ and it ¿didn¿t cover he usual pain area. ¿ the patient¿s settings adjusted back on (b)(6) 2020. Prior to the (b)(6) 2020 visit, the patient reported ¿no issues with recharging and stated that her recharge intervals were every 2-3 days. ¿ the patient was given a new patient programmer and recharger in an attempt to troubleshoot the issue; however, the issue remained unresolved. The patient stated that she was using the original recharger and the second recharger to charge just one bar. The patient¿s physician then adjusted certain settings on the patient¿s program such as the pulse width and the voltage in a hope to reduce the patient¿s battery consumption. However, the patient reported that as of (b)(6)2020, it was ¿still taking her three battery packs to charge her implant. ¿ the patient ¿had been especially trying to charge her last bar for the past eight hours¿ at that time and that she ¿used three bars of her fully recharged controller to charge that one bar. ¿ the recharger battery pack was 100% charged when she started charging. The patient noted she would ¿lose a bar on the implant very quickly if she took the charger off. ¿ the patient ¿had to charge very frequently,¿ having to charge more than once a day. Within a half hour she would go down by a quarter in her charge level. The patient was given a new, third recharger on (b)(6) 2020 and was able to charge to 100% after three days of charging and a while night or recharging as of (b)(6) 2020. There were no falls or changes in therapy reported. The patient woke up on (b)(6) 2020 when she realized that her stimulation was off and proceeded to charge the ins at that time. The patient charged the ins to about 50% and then took the recharger off for a shower. During the 15 minutes away from the charger, the patient¿s ins battery ¿went flat. ¿ additional recharger was then attempted, whereby it took about an hour to charge the first bar of the ins battery and was still at one bar after two hours of charging. Impedance testing performed on (b)(6) 2020 again found electrodes 8 and 12 had high impedances of >10000 ohms for all electrode pairings; however, it was also found that electrode pair 11-13 had an impedance of <(><<)>50 ohms. Review of the ins data found no device abnormalities other than the previously noted impedance issues. There were no surgical interventions performed as of (b)(6) 2020; although a surgical intervention was planned, it was not yet scheduled at that time. The patient¿s indication for device use was occipital nerve stimulation for the treatment of headache pain. There were no further complications reported or anticipated.
 
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Brand NameRESTORESENSOR MRI
Type of DeviceSTIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF
Manufacturer (Section D)
MEDTRONIC PUERTO RICO OPERATIONS CO.
road 31, km. 24, hm 4
ceiba norte industrial park
juncos PR 00777
Manufacturer (Section G)
MEDTRONIC PUERTO RICO OPERATIONS CO.
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 Key10617142
MDR Text Key209555798
Report Number3004209178-2020-17086
Device Sequence Number1
Product Code LGW
Combination Product (y/n)N
Reporter Country CodeSN
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,Followup
Report Date 03/31/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received10/01/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date11/14/2018
Device Model Number97714
Device Catalogue Number97714
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received03/16/2021
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured12/19/2017
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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