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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 97714
Device Problems Energy Output Problem (1431); Overheating of Device (1437); Battery Problem (2885); Appropriate Term/Code Not Available (3191)
Patient Problems Pain (1994); Swelling (2091); Burning Sensation (2146); Therapeutic Response, Decreased (2271); Complaint, Ill-Defined (2331)
Event Date 07/01/2018
Event Type  Injury  
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
Information was received from a healthcare professional via a manufacture representative regarding a patient implanted with an implantable neurostimulator (ins). It was reported that the patient was not able to turn their stimulation above 3v without having burning in the battery area. The rep was to meet with the patient to check the ins. No further complications were reported.
 
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
Additional information received from the patient and the manufacture representative reiterated that they were feeling a burning sensation and pain at the ins site. Turning stimulation off did not resolve the issue. It was also noted that there was some swelling at the ins site and that the ins was discharged. The rep was to meet with the patient to troubleshoot after getting the ins charged up. The patient had an mri scheduled on 2018-(b)(6). No further complications were reported.
 
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
Additional information received from the patient reiterated that their feet and back were 'killing them' and that the ins was suppose to stimulate their back and legs but was not doing so. The patient also felt pain in their knee. No further complications were reported.
 
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
Additional information was reported that the patient stated she wanting to find a new healthcare provider (hcp) to just take the entire device out. The patient stated the manufacturing representative (rep) rep tried to help her and did everything she could, but the nurse said the patient will need to discuss this with the doctor. The patient stated she then was told she was going to have to wait until the 26th. The patient stated she can't live with this pain. The patient noted that when the device worked it gave her 80% relief. No further information was reported.
 
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
Additional information was received from a healthcare provider (hcp) via manufacturer representative (rep) reporting that the patient will have a complete spinal cord stimulator explant. The date of the planned explant is (b)(6) 2019. No further complications were reported/anticipated.
 
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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 Key7718440
MDR Text Key115119287
Report Number3004209178-2018-16586
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,Followup,Followup,Followup
Report Date 02/14/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/25/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date02/14/2016
Device Model Number97714
Device Catalogue Number97714
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received02/04/2019
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured03/26/2015
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: 07/25/2018 Patient Sequence Number: 1
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