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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 Problems Low Battery (2584); Device Displays Incorrect Message (2591); Device Operates Differently Than Expected (2913); Environmental Compatibility Problem (2929)
Patient Problems Pain (1994); Therapeutic Response, Decreased (2271)
Event Date 03/13/2015
Event Type  malfunction  
Manufacturer Narrative
Concomitant medical products: product id: 97740, serial# (b)(4), product type: programmer, patient; product id: 977a260, serial#(b)(4), implanted: (b)(6) 2015, product type: lead; product id: 977a260, serial# (b)(4), implanted: (b)(6) 2015, product type: lead. If information is provided in the future, a supplemental report will be issued.
 
Event Description
On (b)(6) 2015, the patient reported a loss of therapy. Stimulation was not helping his pain like it used to. The change in therapy/symptoms was considered gradual. This occurred in (b)(6) 2015. The patient's relevant medical history includes non-malignant pain and chronic low back pain. No interventions or outcome were reported regarding this event. Further follow-up is being conducted to obtain additional information. If additional information is received, the event will be updated. On (b)(6) 2018, additional information was received from the patient¿s friend/family member reporting that they had been having back pain. The caller was asking if the manufacturer representative (rep) could meet with the patient at the hospital (patient is in hospital for reasons unrelated to their device/therapy). The patient stated they were off all pain pills and was not using their stimulator because it did not help them. They stated when they first got their stimulator it was working and then about a month after that, the patient was scrubbing the carpet and since then the stimulator had not worked the same. The patient had an appointment to meet with their physician assistant and rep in a couple of weeks. It was reported that the patient needed an mri of the head, not related to the their implant. During the call, the caller stated they saw the eri on the programmer. Patient services helped them clear the eri. It was stated the programmer showed the ins was off, they stated they knew this because it was not working for the patient. It was reported that the pain in the back began about a month after implant (2015). 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 Key7575548
MDR Text Key110704172
Report Number3004209178-2018-12793
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
Report Date 06/06/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received06/06/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date05/14/2016
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 Received06/04/2018
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured11/24/2014
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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