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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 97702
Device Problem Device Operates Differently Than Expected (2913)
Patient Problems Pain (1994); Malaise (2359)
Event Type  malfunction  
Manufacturer Narrative
Corrected information: sex, date of birth. If information is provided in the future, a supplemental report will be issued.
 
Event Description
Information was received from a consumer regarding a patient who was implanted with a neurostimulator for cervical/neck spinal pain. It was reported that the patient was having a great deal of difficulty with the device. It was further stated that they were having a lot of pain around the device and was sick. The patient did not think the device was working anyway. Per the patient, the health care professional (hcp) asked them to turn the device off so the device had been off for 2 days. The patient needed to meet a manufacturer representative to check the device and make sure it was working properly and also to see what was going on. The process of having the hcp request a manufacturer representative to meet the patient at the hcp office was reviewed. The event date was not able to be collected during the call.
 
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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 clark
7000 central avenue ne rcw215
minneapolis, MN 55432
7635263920
MDR Report Key6294686
MDR Text Key101986241
Report Number3004209178-2017-02338
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 02/01/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received02/01/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date05/28/2017
Device Model Number97702
Device Catalogue Number97702
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 Received01/30/2017
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured12/12/2015
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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