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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC PUERTO RICO OPERATIONS CO. RESTORE SENSOR STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR

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MEDTRONIC PUERTO RICO OPERATIONS CO. RESTORE SENSOR STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR Back to Search Results
Model Number 37714
Device Problems Unstable (1667); Delayed Charge Time (2586); Charging Problem (2892); Communication or Transmission Problem (2896)
Patient Problems Pain (1994); Discomfort (2330)
Event Date 09/30/2014
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 manufacturer representative regarding a patient who was implanted with an implantable neurostimulator (ins) for non-malignant pain. Caller is with the pt and notes that since implant, the pt has had trouble charging. The caller states that the pt uses adhesive discs and she puts any pressure at all on the antenna over the ins she loses coupling from 8 to 0 boxes. The rep had a spare ins recharger (insr) and was able to replicate this with the spare insr. Pt states she can't lean back, has to walk with the antenna loose connected to the adhesive disc and it is painful and uncomfortable. The pt states that she had to charge for 7 hours to get from 0-100% (flashing last quartile) yesterday. The caller notes the ins in the pocket has a slight tilt. Tss reviewed based on caller's info it is unlikely that replacing product will resolve the issue. The caller notes the will look at pocket but ultimately may look at replacement soon. Additional information was received from the rep, it was reported that appt scheduled for (b)(6) 2021 with neurosurgery p. A. The issue was not resolved. No explant scheduled at this time.
 
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Brand NameRESTORE SENSOR
Type of DeviceSTIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR
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 Key12534523
MDR Text Key273415362
Report Number3004209178-2021-14446
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 company representative
Reporter Occupation
Type of Report Initial
Report Date 09/27/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received09/27/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date04/14/2015
Device Model Number37714
Device Catalogue Number37714
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/03/2021
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured05/22/2014
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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