• Decrease font size
  • Return font size to normal
  • Increase font size
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

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

MEDTRONIC PUERTO RICO OPERATIONS CO. SURESCAN STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF Back to Search Results
Model Number 97713
Device Problems Intermittent Continuity (1121); Electromagnetic Interference (1194); Failure to Deliver Energy (1211); No Device Output (1435); Device Displays Incorrect Message (2591)
Patient Problems Sepsis (2067); Therapeutic Effects, Unexpected (2099)
Event Date 07/10/2017
Event Type  Injury  
Manufacturer Narrative
A good faith effort will be made to obtain the applicable information relevant to the report. If information is provided in the future, a supplemental report will be issued.
 
Event Description
Information was received form a healthcare professional via a manufacturing representative regarding a patient that was implanted with neurostimulator for spinal pain. It was reported that the patient had had a cardiac arrested and was defibrillated twice. It was confirmed that the cardiac arrest was unrelated to the device. After the defibrillation stimulation was attempted to be turned on but was unable. The caller stated that stimulation had been turning off. The device was interrogated and the screen showed the lightning bolt and stimulation on icon. It was reported that there was a power on reset (por) error code 0x400. The por error code was cleared and the patient was able to feel stimulation in the appropriate areas. The health care professional also reported that the patient came in for electrolyte abnormalities and the patient was being worked up for sepsis. No further complications were reported as a result of this event.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

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 Key6713642
MDR Text Key80036144
Report Number3004209178-2017-14830
Device Sequence Number1
Product Code LGW
Combination Product (y/n)N
PMA/PMN Number
P840001
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation
Type of Report Initial
Report Date 07/14/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/14/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date10/14/2015
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 Received07/13/2017
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured09/16/2014
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: 07/14/2017 Patient Sequence Number: 1
-
-