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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 97712
Device Problems Battery Problem (2885); Appropriate Term/Code Not Available (3191)
Patient Problems Therapeutic Response, Decreased (2271); No Known Impact Or Consequence To Patient (2692)
Event Date 07/16/2018
Event Type  malfunction  
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
Information was received from a consumer regarding an implantable neurostimulator (ins) for the treatment of non-malignant pain. It was reported that there was a por seen. The patient's therapy stopped due to por. The patient reported that they had driven a long time that day and it was the only thing out of normal. The patient stated that the por was informational. The patient was walked through the steps to clear the por and it was cleared successfully. No further complications were reported or anticipated.
 
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.
 
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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
lisa woodward clark
7000 central avenue ne rcw215
minneapolis, MN 55432
7635263920
MDR Report Key7718410
MDR Text Key115413444
Report Number3004209178-2018-16585
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,Followup
Report Date 10/03/2018
1 Device was Involved in the Event
0 Patients were 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 Date11/14/2014
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 Manufactured12/16/2013
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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