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U.S. Department of Health and Human Services

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

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MEDTRONIC PUERTO RICO OPERATIONS CO. SURESCAN STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF Back to Search Results
Model Number 97714
Device Problem Energy Output Problem (1431)
Patient Problems Dizziness (2194); Ambulation Difficulties (2544)
Event Date 07/01/2018
Event Type  malfunction  
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
Information was received from the manufacturer's representative regarding a patient who was implanted with a neurostimulator for spinal cord stimulation - spinal pain. It was reported that the patient was light-headed and off balance. The manufacturer's representative (rep) met with the patient today to check stimulator after patient reported of feeling light-headed. Light headed was usually in the morning but was sporadic throughout the day. Patient did monitor blood pressure but caller could not confirm if he was on medication and did not think he was. Patient called their healthcare provider and was told to see his family practice doctor and did give patient a clean bill of health. Patient was programmed sub-threshold in an ld configuration. The rep suggested the patient to turn stim off for several days to see if this issue changes. It was reported this was a sudden change in therapy/symptoms. No further complications were reported/anticipated.
 
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
Additional information was received from the manufacturer's representative. It was reported that cause was not determined. No actions were taken to resolve the issue.
 
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
Additional information was received from the manufacturer's representative. It was reported the patient had an mri and ct scan, the mri showed a spinal compression issue where the lead was. The patient is being seen on thursday by an hcp. Patient wants to keep system because it helps him.
 
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
Additional information was received from the manufacturer's representative. It was reported that the hcp did not think the lead was causing the compression. The hcp stated they might decompress via laminotomy the are because it might be too narrow in the area the lead was. The potential surgery was not scheduled yet as far as the rep knew.
 
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Brand NameSURESCAN
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
lisa woodward clark
7000 central avenue ne rcw215
minneapolis, MN 55432
7635263920
MDR Report Key7789071
MDR Text Key117963281
Report Number3004209178-2018-18397
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,Followup,Followup,Followup
Report Date 12/03/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received08/16/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date05/28/2018
Device Model Number97714
Device Catalogue Number97714
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 Received11/26/2018
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured07/07/2017
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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