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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 Migration or Expulsion of Device (1395); Unintended Collision (1429); Insufficient Information (3190)
Patient Problem Insufficient Information (4580)
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 (pt) regarding an implantable neurostimulator (ins). The reason for call was pt reported that they have fallen 6 times, always on their stomach or face and on concrete or pavement, and their stimulator moved completely away from their scar and then the stimulator moved back into place. Pt said that now there are two pieces that they think broke in half and the stimulator quit working. Pt said that they can feel both pieces that broke in half in their stomach and they are sticking out. The patient was redirected to their healthcare provider to further address the issue. When the pt was asked when they fell, the pt said about a month and a half ago. Pt said that they were going to get in touch with their va doctor regarding the issue.

 
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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 Key12396150
MDR Text Key271267196
Report Number3004209178-2021-13169
Device Sequence Number1
Product Code LGW
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberP840001
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type CONSUMER
Reporter Occupation
Type of Report Initial
Report Date 08/31/2021
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received08/31/2021
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date12/14/2016
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 Received08/25/2021
Was Device Evaluated By Manufacturer? No Answer Provided
Date Device Manufactured01/20/2016
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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