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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 97712
Device Problems Decoupling (1145); Charging Problem (2892); Communication or Transmission Problem (2896)
Patient Problems Unspecified Infection (1930); Pain (1994); Patient Problem/Medical Problem (2688); No Code Available (3191)
Event Date 06/01/2018
Event Type  Injury  
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
(b)(6) 2018; (b)(4): information was received from a patient with an implantable neurostimulator (ins) for the treatment of non-malignant pain. It was reported that the patient had an infection when they went to get the staples removed. The patient¿s wife called a manufacturer representative (rep) because the incision was ¿oozing¿. The patient stated they were getting only 4 coupling bars filled and now they could not get any. The patient stated they had a lot of bandages on the incision site because of the infection and they were getting all the bars but none were shaded in. The patient was recommended to call back when the incision healed and there were no more bandages. Additional information from the rep stated that the patient was prescribed antibiotics by their physician and when they met with the patient at post-op they got excellent coupling so they told the patient they needed to reposition the antenna. No further patient complications were reported as a result of this event.
 
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
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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
lisa woodward clark
7000 central avenue ne rcw215
minneapolis, MN 55432
7635263920
MDR Report Key7669783
MDR Text Key113420244
Report Number3004209178-2018-15249
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 10/04/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/09/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date07/14/2018
Device Model Number97712
Device Catalogue Number97712
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/08/2018
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured08/17/2017
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: 07/09/2018 Patient Sequence Number: 1
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