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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 97713
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Wound Dehiscence (1154); Erythema (1840); Unspecified Infection (1930); Pain (1994); Discomfort (2330); Skin Inflammation (2443); Alteration In Body Temperature (2682)
Event Date 04/22/2018
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 consumer via a manufacturer representative regarding a patient who was implanted with a neurostimulator for spinal pain. It was reported that the patient had redness, tenderness, and warm to the touch at the generator pocket incision. The discomfort was noticed on (b)(6) 2018. There were no known environmental factors. The patient did not have a fever but was instructed to see a health care provider (hcp) regarding possible infection. The appointment was scheduled for the day of the report ((b)(6) 2018). There were no interventions taken at the time of the report. It was unknown if the issue resolved. No further complications were reported.
 
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
Additional information was received from the manufacturer representative (rep) reporting that the patient was seen by their practitioner, however, they did not have any further information regarding their prognosis as the patient nor the physician had called back with any update. It was reported that this was all the information the rep had at this time. No further complications were reported/anticipated.
 
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
Additional information received from the patient indicated that the physician looked at their implant site, and it felt some heat from the area. The physician assumed the site was infected, and the patient was given antibiotics for 10 days to resolve the issue. No further complications were reported or anticipated.
 
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
Additional information received from the patient via the manufacture representative reported that they had 2 dime sized blisters at the incision site which burst open at were causing pain. It was noted that the stimulation and recharging were both functional. The patient was suppose to meet with their hcp within the next few of weeks to address the issue. No further complications were reported.
 
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
Additional information was received from the manufacturer representative (rep) 2019-05-13. It was reported that the patient was seeing a new pain management physician because she had recently been treated for an infection at her battery site as well as an area along her lead in the middle of her back. She was treated with two rounds of antibiotic therapy approximately one month ago. She noticed at this time a small opening above her ipg. Patient saw pain management physician yesterday and was referred to neurosurgery to potentially have device removed. No further complications were reported/anticipated.
 
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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 woodward clark
7000 central avenue ne rcw215
minneapolis, MN 55432
7635263920
MDR Report Key7466371
MDR Text Key106673236
Report Number3004209178-2018-09420
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 company representative,consum
Reporter Occupation
Type of Report Initial,Followup,Followup,Followup,Followup
Report Date 05/31/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/26/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date03/28/2018
Device Model Number97713
Device Catalogue Number97713
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 Received05/13/2019
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured03/03/2017
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: 04/26/2018 Patient Sequence Number: 1
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