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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, IMPLANTED (PAIN RELIEF)

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MEDTRONIC PUERTO RICO OPERATIONS CO. SURESCAN STIMULATOR, SPINAL-CORD, IMPLANTED (PAIN RELIEF) Back to Search Results
Model Number 97714
Device Problem Malposition of Device (2616)
Patient Problems Unspecified Infection (1930); Pain (1994); Pocket Erosion (2013); Complaint, Ill-Defined (2331); Malaise (2359)
Event Date 06/01/2016
Event Type  Injury  
Manufacturer Narrative
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 a neurostimulator for non-malignant pain. It was reported that when the patient saw the health care provider, he noted that the implantable neurostimulator appeared too close to the surface and told the patient that it "doesn't look good. " the patient has had no fall or trauma or significant weight loss. The patient stated that it is painful, and after seeing the health care provider the day prior to the report, they are checking for infection in addition to another follow-up appointment on (b)(6) 2016. This had been occurring since (b)(6) of 2016.
 
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
Additional information was received from a consumer on 2017-02-24 reported that the health care professional (hcp) checked the ins and it was too close to the surface of the skin of their rear end. It was exposed and ¿you can see it. ¿ the device coming to the surface occurred in (b)(6) 2015. They went to the hcp and ¿it should not be looking that way. ¿ the patient reported that their health had not been good and it might be an infection. It was reported that there was erosion at the ins. There was a potential infection as there was erosion through their skin and the ins was sticking out of their rear end. The information was not confirmed. The patient had reported the issue to their hcp and they would be meeting next week to test for infection. The patient stayed indoors and was lately feeling sick and not feeling well. The patient wanted to deal with their back. Since implant the pain was excruciating and it was a misery.
 
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Brand NameSURESCAN
Type of DeviceSTIMULATOR, SPINAL-CORD, IMPLANTED (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 clark
7000 central avenue ne rcw215
minneapolis, MN 55432
7635263920
MDR Report Key5972034
MDR Text Key102483959
Report Number3004209178-2016-19530
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
Report Date 02/27/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/22/2016
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date09/14/2015
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 Received02/24/2017
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured10/27/2014
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: 09/22/2016 Patient Sequence Number: 1
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