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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

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MEDTRONIC PUERTO RICO OPERATIONS CO. SURESCAN STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR Back to Search Results
Model Number 97713
Device Problems Intermittent Continuity (1121); Failure to Interrogate (1332); Delayed Charge Time (2586); Charging Problem (2892); Communication or Transmission Problem (2896); Insufficient Information (3190)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 02/01/2021
Event Type  malfunction  
Manufacturer Narrative
Concomitant medical products: product id: 97713, serial#: (b)(4), implanted: (b)(6) 2015. Product type implantable neurostimulator refer to regulatory report# (b)(4). The patient had two implanted systems and it was not clear which issues pertained to which implanted system. The referenced report pertains to the patient¿s other system. If information is provided in the future, a supplemental report will be issued.
 
Event Description
It was reported that around (b)(6) 2021, the patient was getting "intermittent signals from the leads" so they were "changed", which was explained to mean they had to change which ones were on, which ones were off, and disabled one of the leads.   since those changes were made, the patient went from charging every 6 days to every 3 days, so the patient was using adhesive discs more frequently.   no symptoms reported. Additional information was received from the patient. The patient clarified that the left leg stimulation was intermittent one time. No signal for period lasting hours and then suddenly it would turn on and the stimulation was felt in left leg. The patient was unaware of any factors/circumstances that led to this. The patient also clarified the "leads were changed. " they noted they were reprogrammed in closed print out of setting in 2010 and other 2021 showing changes made since then. Have had to increase amplitude to cover. Recharging went from 6 days to every 3 days, which made a big impact on their life taking 3. 5 to 4 hours.
 
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Brand NameSURESCAN
Type of DeviceSTIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR
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
glen belmer
7000 central avenue ne rcw215
minneapolis, MN 55432
6122713209
MDR Report Key12417166
MDR Text Key271280472
Report Number3004209178-2021-13319
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
Report Date 10/14/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received09/02/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date04/14/2016
Device Model Number97713
Device Catalogue Number97713
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/20/2021
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured03/16/2015
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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