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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 97714
Device Problems Energy Output Problem (1431); Unable to Obtain Readings (1516); Device Operates Differently Than Expected (2913)
Patient Problems Pain (1994); Therapeutic Effects, Unexpected (2099); Tingling (2171)
Event Date 04/18/2018
Event Type  malfunction  
Manufacturer Narrative
Concomitant medical products: product id: 97714, serial# (b)(4), implanted: (b)(6) 2017, explanted: product type implantable neurostimulator. It was noted that the patient had 2 implantable neurostimulators (ins) present during the event. See manufacturer¿s report # 3004209178-2018-11286 for the concomitant ins information. If information is provided in the future, a supplemental report will be issued.
 
Event Description
Information was received from a patient via manufacturer representative regarding patient's neurostimulator (ins) that was implanted for spinal pain and non-malignant pain. It was reported that patient feels pulsating sensation in his ins pocket area when he lies on that area and when he bends over. The pulsating is like a heartbeat. Patient has been using hd programming and his current hd settings for a long time. Patient usually doesn't feel stim with his hd settings, though sometimes he can feel a light tingling. Caller tried programming ld settings today but this didn't resolve the issue. Patient does not feel sensation with stim off. Palpation of ins area with stim on did not create any changes in stim. Patient does note that when the pulsating is occurring that his stimulation does feel different. Impedances taken with patient in position that causes this pulsating did not reflect any changes in impedances. (initial check of imped did show "xxx" on all pairs with 0 except #13, which showed 2950 ohms). Caller remeasured impedances and then these values normalized. No trauma/falls were reported that could be related to this issue. Patient can turn the stim down and then this pulsating isn't felt as strongly, but then patient doesn't get the pain relief he needs when using lower voltage. The pulsating issue started in (b)(6) 2018; an exact date was not provided. They will keep an eye on the issue for now. No further complications were reported/anticipated.
 
Manufacturer Narrative
Additional information indicated that the device associated with the complaint originally reported was captured in regulatory report (b)(4): product id (b)(4) serial# (b)(4) implanted: (b)(4) 2017: product type implantable neurostimulator. If information is provided in the future, a supplemental report will be issued.
 
Manufacturer Narrative
Manufacturer¿s report was incorrectly submitted on this device. There is no information to reasonably suggest that the device in this report may have caused or contributed to a death or serious injury or that the device in this report has malfunctioned and does not meet the reporting requirements stipulated in 21 cfr 803. Please see the correct manufacturer¿s report # 3004209178-2018-11286. If information is provided in the future, a supplemental report will be issued.
 
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
Additional information was received from the rep. Caller stated that after initial troubleshooting and patient had time to experience updated programming. Caller stated no changes as a result and requested advice on next steps and confirmed that patient could not turn up stimulation to get pain relief. Caller was advised to run additional impedance tests in different positions, reprogram stimulation and possibly obtain imaging to look for damaged leads and discuss next steps with the managing physician. No further complications were reported/anticipated.
 
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
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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 Key7526331
MDR Text Key109004462
Report Number3004209178-2018-11289
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 10/04/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received05/18/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date09/28/2017
Device Model Number97714
Device Catalogue Number97714
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 Received08/08/2018
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured11/07/2016
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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