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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 Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Inflammation (1932); Pain (1994); Staphylococcus Aureus (2058); Malaise (2359); Fluid Discharge (2686)
Event Date 11/08/2016
Event Type  Injury  
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Manufacturer Narrative
Section d references the main component of the system and other applicable components are: product id 97702 lot# serial# (b)(4) implanted: (b)(6) 2016. Explanted: product type implantable neurostimulator b5. See mdr # 3004209178-2017-03716 regarding the other ins. 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 the implantable neurostimulator (ins) was implanted for upper body pain. The incision site was seeping and bandaged after stitched were removed on (b)(6) 2016. It became infected with staphylococcus. The patient felt very sick after surgery and did not feel like they were getting any better. The patient went to the emergency room (er) on (b)(6) 2016. The lead and ins were removed on (b)(6) 2016. The patient had 2 additional surgeries to remove the fluid as they were still very inflamed on (b)(6) 2016. The patient did not leave the hospital until (b)(6) 2016. The patient was on 6 weeks of antibiotics. Since the system was removed the upper body pain was unregulated. It was stated that 2 years ago the patient had been in a car accident and been on opiates ever since. The caller was not sure if they wanted another ins but wanted to get off of the opiates. The patient felt that they had aged and had no energy because of the opiates they had to take. An appointment with the health care professional (hcp) was set to (b)(6) 2017 to start the process of implant again.
 
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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 Key6326072
MDR Text Key100713401
Report Number3004209178-2017-03717
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 02/13/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/13/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date09/14/2017
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 Received02/09/2017
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured03/16/2016
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: 02/13/2017 Patient Sequence Number: 1
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