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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

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MEDTRONIC PUERTO RICO OPERATIONS CO. SURESCAN STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR Back to Search Results
Model Number 97712
Device Problem Migration or Expulsion of Device (1395)
Patient Problems Headache (1880); Dizziness (2194)
Event Date 06/03/2021
Event Type  Malfunction  
Manufacturer Narrative

Concomitant medical products: product id neu_unknown_lead, serial# unknown, explanted: (b)(6) 2021, product type: lead. Product id neu_unknown_lead, serial# unknown, product type: lead. Other relevant device(s) are: product id: neu_unknown_lead, serial/lot #: unknown. Product id: neu_unknown_lead, serial/lot #: unknown. If information is provided in the future, a supplemental report will be issued.

 
Event Description

Information was received from a patient via manufacturer representative who was implanted with an implantable neurostimulator (ins). The patient reported that he has been feeling headaches and dizziness for three weeks. He has not fallen or had an accident. The health care professional performed x-ray images on (b)(6) 2021, and the leads that were placed in 2019 were confirmed to have migrated from the original position that they were implanted in 2019. There were no impedance issues or bad connections. The health care professional recommended only the use of 3 electrodes on the 0-7 lead. The patient was programmed with -1, +2, +3 at 180 microseconds for the pulse width and a rate of 40 hertz. It is unknown at this time if the issue has resolved; however, the patient is under observation and the health care professional will evaluate in 30 days to decide next steps. At this time, no surgical intervention was planned or performed.

 
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Brand NameSURESCAN
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 Key12076022
MDR Text Key258665410
Report Number3004209178-2021-10039
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,Followup,Followup
Report Date 08/05/2021
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received06/28/2021
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date02/28/2017
Device MODEL Number97712
Device Catalogue Number97712
Was Device Available For Evaluation? No
Is The Reporter A Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/03/2021
Was Device Evaluated By Manufacturer? No Answer Provided
Date Device Manufactured04/04/2016
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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