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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 Problems Electromagnetic Interference (1194); Unable to Obtain Readings (1516)
Patient Problems Pain (1994); No Known Impact Or Consequence To Patient (2692)
Event Date 04/17/2018
Event Type  malfunction  
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
Information was received from patient, via manufacturer representative, concerning patient with an implantable neurostimulator (ins) for non-malignant pain. It was reported that there was an impedance issue. The representative was seeing the patient for reprogramming. The representative requested information on how to perform re-orientation. The patient was feeling stimulation. The representative reported that when she performed electrode impedance, all contact pairs except for electrode 13 were showing xxx. Electrode 13 showed normal impedance. No messages were seen when interrogated with clinician programmer. The representative reported that the patient had an mri scan recently and placed the device into mri mode. The mri scan was unrelated to patient¿s device/therapy. Troubleshooting could not be performed due to lack of access to the product, as the patient did not have the recharger with her at the time of the appointment and no recharger was available. No patient symptoms were reported. 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 representative on 04/18/2018. It was reported that the reprogramming was due to the patient having new pain. There was no device or procedure issue. No troubleshooting was performed because they did not have the recharger. No actions had been taken to resolve the impedance issue and the cause was unknown. The patient¿s weight was unknown. It was subsequently reported that the representative was with the patient to test impedances to see if the xxx appeared. The caller was informed that xxx is often just temporary interference. The representative tested the impedances at. 7v and the ins generated results and there was no xxx. No further complications were reported/anticipated.
 
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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 Key7441736
MDR Text Key106144556
Report Number3004209178-2018-08355
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,consum
Reporter Occupation
Type of Report Initial,Followup
Report Date 05/03/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received04/18/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date03/28/2017
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 Received04/18/2018
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured05/09/2016
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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