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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 97702
Device Problem Malposition of Device (2616)
Patient Problems Nerve Damage (1979); Pain (1994); Discomfort (2330)
Event Date 03/29/2016
Event Type  Injury  
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
Information was received from a consumer regarding a patient who was implanted with a neurostimulator for spinal pain. It was reported that when the patient got implanted and woke up from anesthesia they were in extreme pain. Per the report, the health care professional (hcp) messed up a lot of the patient¿s nerves in their stomach where they put the ins in. They messed around and hit some nerves in their abdomen. It was reported that the patient had to be taken to the regular hospital. The patient was there for 5 days after they were implanted so that the pain could be brought down. The ins was causing the patient discomfort. Before implant, the implanting hcp had told the patient that they would be implanting it in their upper butt cheek area but when the patient came out of surgery the device was in their lower back. It was right on top of their plates and screws. The patient mentioned that they lost some weight in the summer time. About (b)(6) 2016, the managing pain hcp had taken x-rays of the patient¿s back which showed that the ins was on top of the patient¿s plates and screws. This hcp wanted the patient to have the ins taken out because it was causing discomfort. The patient requested hcp listings for surgeons as their managing pain hcp told them to find a surgeon to take the device out.
 
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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 clark
7000 central avenue ne rcw215
minneapolis, MN 55432
7635263920
MDR Report Key6298181
MDR Text Key102358926
Report Number3004209178-2017-02440
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 02/02/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/02/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date01/14/2017
Device Model Number97702
Device Catalogue Number97702
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 Received02/01/2017
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured07/15/2015
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: 02/02/2017 Patient Sequence Number: 1
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