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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 97714
Device Problems Malposition of Device (2616); Adverse Event Without Identified Device or Use Problem (2993); Insufficient Information (3190)
Patient Problems Abdominal Pain (1685); Nerve Damage (1979); Pain (1994); Cognitive Changes (2551); No Clinical Signs, Symptoms or Conditions (4582)
Event Date 03/31/2016
Event Type  malfunction  
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Manufacturer Narrative
A good faith effort will be made to obtain the applicable information relevant to the report. If information is provided in the future, a supplemental report will be issued.
 
Event Description
A patient reported he needs an mri because ever since the implantable neurostimulator (ins) was implanted he has had abdominal pain. The patient states after implant surgery he was in the hospital for 9 days. The patient further reported that if they can't figure out how to resolve, then he wants the ins removed. The patient stated he needs to have an mri of the abdomen and according to his device manufacturer registration and his patient programmer he is mri full body eligible. The patient stated the problem is that the mri facility has the paperwork from the healthcare provider (hcp) who performed the implant and this paperwork shows that the pt has a non surescan lead and the mri facility won't do the mri because of the discrepancy. The hcp who performed the implant could not be contacted for verification. The patient wanted to know how he can find out what lead is in the body. It was reviewed that the patient programmer mri mode displaying mri eligibility was not reading what is in the body, but rather information that it was programmed to show. The patient was informed that they could have an x-ray to determine if they are surescan leads or not. The patient was redirected to their healthcare provider. The indication for implant was spinal pain.
 
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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
glen belmer
7000 central avenue ne rcw215
minneapolis, MN 55432
6122713209
MDR Report Key6508466
MDR Text Key102747108
Report Number3004209178-2017-08731
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,literature
Reporter Occupation
Type of Report Initial,Followup,Followup,Followup
Report Date 10/21/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/20/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date06/14/2016
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 Received09/27/2021
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured07/22/2015
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 04/20/2017 Patient Sequence Number: 1
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