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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 Problems Failure to Deliver Energy (1211); Unintended Collision (1429); Energy Output Problem (1431); Inappropriate/Inadequate Shock/Stimulation (1574); Insufficient Information (3190); Patient Device Interaction Problem (4001)
Patient Problems Electric Shock (2554); No Clinical Signs, Symptoms or Conditions (4582)
Event Date 05/31/2021
Event Type  malfunction  
Manufacturer Narrative
Concomitant medical products: product id: 977a260, serial#: (b)(4), product type: lead. Product id: 977a260, serial#: (b)(4), product type: lead. Product id: 977a260, serial/lot #: (b)(4), ubd: , udi#: (b)(4); product id: 977a260, serial/lot #: (b)(4), ubd: , udi#: (b)(4). Date of event is year valid. If information is provided in the future, a supplemental report will be issued.
 
Event Description
Information was received from a patient who was implanted with an implantable neurostimulator (ins) for spinal pain. It was reported that their stimulation was not working, it would give them one shock and then quit when they try to turn stim on with their patient programmer (would show the lightening bolt indicating stim was on). The patient said they do not use an antenna with their patient programmer. The patient said when they turn their stimulation on using their recharger, it will turn on, but the stimulation would be "going too fast" and they can't turn it down so they just turn it off. The patient said their programmer batteries showed full charge and the ins was about half charged. An email was sent to the repair department to replace the device. It was reviewed that if the replacement patient programmer does not resolve their problem, they should follow up with their healthcare provider (hcp) for further troubleshooting and to check the ins. The patient called back and was able to use the patient programmer to connect to the implant and the patient programmer showed settings 8. 5v and therapy is on but the patient was not feeling stimulation. It was asked if the patient had a fall or trauma and the patient stated he tripped over a post 4 days ago. Patient stated he thinks something happened with his lead because when he is sitting, there is no stimulation but when he gets up and moves a little then he can feel stimulation. It was reviewed that getting another patient programmer will not change the information on the patient programmer screen or the stimulation. Patient asked about a manufacturer representative (rep) and the rep's role was reviewed and recommend that the patient consult with his healthcare provider for next steps.
 
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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 Key11961192
MDR Text Key255440043
Report Number3004209178-2021-09019
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
Report Date 07/13/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received06/08/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date04/28/2015
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 Received07/07/2021
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured06/12/2014
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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