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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 High impedance (1291); Unintended Collision (1429); Unable to Obtain Readings (1516)
Patient Problems Therapeutic Effects, Unexpected (2099); No Known Impact Or Consequence To Patient (2692)
Event Date 01/01/2016
Event Type  malfunction  
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
Information was received from a consumer regarding an implantable neurostimulator (ins) for the treatment of non-malignant pain. It was reported that the patient had a fall in 2016 and gradually lost stimulation. The caller had a hip replacement due to the fall. The patient has high impedances as follows: at. 7v lead 0-7 shows >10k, at 3v contact 1 and 3 show >40k and the rest showed xxx. The rep performed a short pmr and the impedances were retested. The xxx was gone but all showed > 40k. The caller dropped their reference and reference 1: only 0-7 shows >40k ohms, contact 2-6: ranging from 27k-36k ohms, 8-15: ranging 800-1400 ohms reference 2: contact 8-15 shows 23k-30k ohms. The caller was redirected to the healthcare provider (hcp) and an x-ray was suggested. No further complications were reported or anticipated. No symptoms were reported.
 
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
Additional information received from the manufacturer representative reported that they advised the patient to contact their surgeon¿s office to have an x-ray and discuss options. The cause of the high impedances was not determined and were not resolved.
 
Manufacturer Narrative
Should have been both adverse event and product problem. If information is provided in the future, a supplemental report will be issued.
 
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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 Key7485459
MDR Text Key107470303
Report Number3004209178-2018-10076
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 consumer
Reporter Occupation
Type of Report Initial,Followup,Followup,Followup
Report Date 05/30/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received05/03/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date06/14/2017
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 Received05/30/2018
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured07/26/2016
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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