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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 97714
Device Problems Break (1069); Failure to Deliver Energy (1211); High impedance (1291); Delayed Charge Time (2586); Patient Device Interaction Problem (4001)
Patient Problems Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Event Date 04/05/2021
Event Type  Injury  
Manufacturer Narrative
Concomitant products: product id: 3778-60, serial#: (b)(4), implanted: (b)(6) 2018, explanted: (b)(6) 2021, product type: lead. Product id: 3778-60, serial#: (b)(4), implanted: (b)(6) 2018, explanted: (b)(6) 2021, product type: lead. Other relevant device(s) are: product id: 3778-60, serial/lot #: (b)(4), ubd: 02-feb-2020, udi#: (b)(4); product id: 3778-60, serial/lot #: (b)(4), ubd: 02-feb-2020, udi#: (b)(4). Device evaluated by mfr: analysis results were not available at the time of this report. A follow-up report will be sent when analysis is completed. H6 codes belong to the leads. If information is provided in the future, a supplemental report will be issued.
 
Event Description
Information was received from the consumer via the manufacturer representative regarding a patient with an implantable neurostimulator (ins) for occipital nerve stimulation. It was reported that the patient presented with slow charging issues which escalated to loss of stimulation on one side. It was discovered that there was high impedance on the right lead. The patient has had no falls but a contributing factor was the patient turns her head a lot. Troubleshooting was performed on (b)(6) 2021. Tested impedance at each connecting point (battery, extensions and leads) to determine the location of the issue. Only one lead was fractured, it was unknown which lead it was. It was noted that the patient was only booked for investigation of the cause of the high impedance. The surgeon wanted to determine the site of the high impedance (leads or extension) to determine if lead replacement would be needed. The patient preferred not to have to shave her head and get the leads replaced if it wasn¿t a lead issue, therefore the operating room was only booked on (b)(6) 2021 for the purpose of checking if it was a lead or extension issue. Both leads were replaced on (b)(6) 2021 and the impedance checks were okay. The ins remained implanted as it had no issues. The issue was resolved at the time of this report. The patient w as alive with no injury.
 
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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
david gustafson
7000 central avenue ne rcw215
minneapolis, MN 55432
7635149628
MDR Report Key11724187
MDR Text Key247265881
Report Number3004209178-2021-06650
Device Sequence Number1
Product Code LGW
Combination Product (y/n)N
Reporter Country CodeSN
PMA/PMN Number
P840001
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial,Followup
Report Date 06/28/2021
1 Device was Involved in the Event
1 Patient was 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 Expiration Date11/14/2018
Device Model Number97714
Device Catalogue Number97714
Was Device Available for Evaluation? No
Date Returned to Manufacturer04/15/2021
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/18/2021
Was Device Evaluated by Manufacturer? No
Date Device Manufactured12/19/2017
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: 04/26/2021 Patient Sequence Number: 1
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