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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 Wound Dehiscence (1154); Purulent Discharge (1812); Rash (2033); Complaint, Ill-Defined (2331); Malaise (2359); Post Operative Wound Infection (2446); Fluid Discharge (2686)
Event Date 11/01/2017
Event Type  Injury  
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
Additional information was received from the patient. The patient reported that 4 days after his new neurostimulator (ins) was implanted, he got sick and was still sick and wasn¿t sure if this was caused by the ins or the surgeon/surgery. The patient reported that the healthcare provider (hcp) took a sample of the drainage and had it tested. The patient reported that he received a call from an infectious disease specialist who told him he had enterococeus and still had this. The patient confirmed the previously reported rash. The patient reported that he was still experiencing ¿drainage¿ from his back. The patient also reported that his incision ¿ruptured¿ and had puss. The patient reported that they saw their hcp on (b)(6) 2017. No further complications were reported.
 
Manufacturer Narrative
Concomitant medical products: product id 39565-65, serial#: (b)(4), implanted: (b)(6) 2010, explanted: (b)(6) 2017, product type: lead. If information is provided in the future, a supplemental report will be issued.
 
Event Description
Additional information was received from the patient. The patient reported that he had to have his neurostimulator (ins) and leads removed in (b)(6) 2017 because he developed an infection post implant (b)(6) 2017. The patient reported the he ¿drained out of the back until (b)(6) 2018. No further complications were reported.
 
Manufacturer Narrative
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 patient had their implantable neurostimulator (ins) replaced due to normal battery depletion. About 4 days after the replacement, the patient developed a rash all over their body and on their head. It was noted that the consumer was not sure where the rash started. The patient went back to their health care provider (hcp) and both the rash and incision site were looked at. There was no inflammation according to the hcp. Per the caller, the hcp did not believe the ins battery caused the rash. The patient had seen multiple hcps for this issue, had been to the emergency center twice, had 4 shots, and 7 prescriptions but the rash was not resolved. This event started in early (b)(6) 2017. The patient would be seeing a dermatologist on friday ((b)(6) 2017). Additional information was received from the consumer on 2017-dec-18 reporting that they gave the patient a cream for their rash but it did not help. The incision opened on (b)(6) 2017 and the health care provider (hcp) told the patient that the system was infected. It was reported that the infection had to have been during the battery replacement surgery. The whole system was removed on (b)(6) 2017. It was planned for the patient to have a new replacement after the new year. No further complications were reported.
 
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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 Key7131026
MDR Text Key103223180
Report Number3004209178-2017-26300
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 06/08/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/19/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date12/14/2018
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 Received06/06/2018
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured06/15/2017
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: 12/19/2017 Patient Sequence Number: 1
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