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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC MED REL MEDTRONIC PUERTO RICO SURESCAN STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF

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MEDTRONIC MED REL MEDTRONIC PUERTO RICO SURESCAN STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF Back to Search Results
Model Number 97714
Device Problems Improper or Incorrect Procedure or Method (2017); Delayed Charge Time (2586); Battery Problem (2885); Insufficient Information (3190)
Patient Problem Sleep Dysfunction (2517)
Event Date 12/01/2019
Event Type  Injury  
Manufacturer Narrative
Concomitant medical products: product id: 39565-65, serial#: (b)(4), implanted: (b)(6) 2014, product type: lead. Other relevant device(s) are: product id: 39565-65, serial/lot#: (b)(4), ubd: 02-jul-2017, udi#: (b)(4). If information is provided in the future, a supplemental report will be issued.
 
Event Description
Information was received from a consumer regarding a patient with an implantable neurostimulator (ins). It was reported that the ins was replaced because it was jumpstarted 2 times, and the 2nd time it would not restart. The overdischarge occurred in (b)(6) 2019 and a rep was unable to get it started, so they determined the ins should be replaced. The patient said the overdischarge occurred because of the settings it was on, noting it would take 3-4 hours to charge the ins, but then the battery would last maybe a day. They mentioned not being able to sleep well due to not having a new implant placed/not having therapy while the ins was overdischarged. The patient called back on a later date and said that over the past year he had numerous problems with the programming of the ins. The patient thought there was possible issues with the leads, so they would more than likely need to be replaced when the ins was replaced. However, the lead replacement did not happen. No further complications were reported.
 
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Brand NameSURESCAN
Type of DeviceSTIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF
Manufacturer (Section D)
MEDTRONIC MED REL MEDTRONIC PUERTO RICO
road 31, km. 24, hm 4
ceiba norte industrial park
juncos PR 00777
Manufacturer (Section G)
MEDTRONIC MED REL MEDTRONIC PUERTO RICO
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 Key10206625
MDR Text Key199244530
Report Number3004209178-2020-11233
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 06/29/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/29/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date10/28/2014
Device Model Number97714
Device Catalogue Number97714
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/29/2020
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured12/06/2013
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: 06/29/2020 Patient Sequence Number: 1
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