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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 High impedance (1291); Inappropriate/Inadequate Shock/Stimulation (1574); Battery Problem (2885); Patient Device Interaction Problem (4001)
Patient Problems Electric Shock (2554); No Clinical Signs, Symptoms or Conditions (4582)
Event Date 02/01/2021
Event Type  malfunction  
Manufacturer Narrative
Concomitant medical products: product id: 7495-51, serial#: (b)(4), implanted: (b)(6) 2001, product type: extension. Product id: 7495-51, serial#: (b)(4), implanted: (b)(6) 2001, product type: extension. Other relevant device(s) are: product id: 7495-51, serial/lot #: (b)(4), ubd: 15-aug-2005, udi#: (b)(4). Product id: 7495-51, serial/lot #: (b)(4), ubd: 15-aug-2005, udi#: (b)(4). Coding for extensions: (b)(4). If information is provided in the future, a supplemental report will be issued.
 
Event Description
The manufacturer representative (rep) reported that "a couple months" after the (b)(6) 2020 implant the patient started experiencing jolting shocks where the lead connects to the extension.   the patient turned off the device in (b)(6) 2020, and the shocking had stopped.   the rep interrogated the ins on (b)(6) 2020, and checked impedances, and found the 8-15 lead with impedances that were over 10,000 ohms and had an "x" for connectivity, so it was un-usable.   they attempted reprogramming using the 0-7 lead, but they had to use every contact and increase the amplitude pretty high for the patient to feel any type of stimulation.   the issue could not be resolved with troubleshooting.   the rep explained that after reprogramming, the end replacement indicator (eri) started appearing.   technical services (ts) assisted the rep with determining the current voltage using the clinician programmer and it was reported that the ins still had a voltage of 2. 97v.   the previous settings were reported to be set at 2. 9v, 450us, 40 hz, which were rev iewed to be incredibly high, and reviewed that there could possibly be a possible short in the system or the reprogramming could have caused the ins voltage to dip below 2. 6v, which would have triggered the eri.   given that the ins voltage was still at 2. 97v, it w as reviewed that the ins was still usable, but the eri will appear every time they interrogate the patient's ins.   there was no report of trauma from the patient and no documented history that the rep was aware of that indicated high impedances on contacts 8-15 at the time of the ins implant.   it was noted the current ins was in the same pocket that the previous ins had been sitting in within the left abdomen.   the rep was advised to have the patient see their doctor for imaging to determine if there are visible issues at the extension-lead site, and also reviewed that the extensions and leads were very old, so discussing next steps with the physician would be necessary.   the rep reported on april 23, 2021 that the physician was going to "do a case" to investigate the possible issue and requested if the physician could use ct or x-ray imaging to look for possible damage.   ts reviewed imaging compatibility and guidelines to address this issue.   no symptoms were reported to be associated with the ins.
 
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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
david gustafson
7000 central avenue ne rcw215
minneapolis, MN 55432
7635149628
MDR Report Key11724665
MDR Text Key247298479
Report Number3004209178-2021-06667
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
Report Date 04/27/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received04/26/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model Number97702
Device Catalogue Number97702
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received04/26/2021
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured07/15/2020
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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