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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 Problem No Known Impact Or Consequence To Patient (2692)
Event Date 01/31/2020
Event Type  Malfunction  
Manufacturer Narrative

Concomitant medical products: product id: 977a290, serial#: (b)(4), implanted: (b)(6) 2016, product type: lead. Other relevant device(s) are: product id: 977a290, serial/lot #: (b)(4), ubd: 26-may-2020, udi#: (b)(4). If information is provided in the future, a supplemental report will be issued.

 
Event Description

Information was received from a patient and manufacturing representative (rep) regarding the patient's implantable neurostimulator (ins). Information was reported that the patient is showing high impedances on electrodes 8, 9, and 10. The connection to the battery is showing x's on the 8, 9, 10 and 11 connections. The patient stated that they had fallen down some steps. Both of the patient's ins were checked and ran impedances on both. The lumbar ins checked out fine. It was the cervical one that had problems. The rep was able to successfully reprogram around the high impedance electrodes. The issue was resolved at the time of the report. Additional information was reported that the cause of the patient's high impedances was not determined. No further information was reported.

 
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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 Key9716634
MDR Text Key179740927
Report Number3004209178-2020-03437
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 COMPANY REPRESENTATIVE,CONSUM
Reporter Occupation
Type of Report Initial
Report Date 02/17/2020
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received02/17/2020
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date06/14/2017
Device MODEL Number97714
Device Catalogue Number97714
Was Device Available For Evaluation? No
Is The Reporter A Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received01/31/2020
Was Device Evaluated By Manufacturer? No Answer Provided
Date Device Manufactured07/23/2016
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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