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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 Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Tinnitus (2103); Dysphasia (2195); Complaint, Ill-Defined (2331); Loss of consciousness (2418)
Event Date 06/17/2018
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 consumer regarding an implantable neurostimulator (ins) for the treatment of head/neck non-malignant pain and spinal pain. It was reported that the patient has the device implanted to treat headaches. The patient has leads on both sides of their temple on the front and back. The patient is experiencing a lot of ringing in their ears and they are trying to figure out if it has anything to do with their stimulator. The patient attempted to contact the manufacturer's representative, but hadn't heard back from them. No further complications were reported or anticipated. No device allegations were made. Additional information was received from a consumer. The consumer reported that the patient had been experiencing a high-pitched volume in his head that caused him to be unconscious. The consumer reported that this noise ¿wipes him out mentally. ¿ the consumer reported that the patient felt like the device was ringing on the inside of his body. The consumer reported that the patient had slurred speech and stutters. The consumer wanted to know if these issues were caused by the device ¿in his head. ¿ the consumer reported that the patient had not had any falls or traumas but has had a significant change in weight loss. The consumer reported that they had shut the device off, but the issues still remained. The consumer noted that the patient was currently experiencing the same issue as he had last year with hearing things and having slurred speech. No further complications were reported.
 
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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 Key9040150
MDR Text Key159514209
Report Number3004209178-2019-17637
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
Report Date 09/13/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/13/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date03/28/2018
Device Model Number97712
Device Catalogue Number97712
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/10/2019
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured05/09/2017
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: 09/13/2019 Patient Sequence Number: 1
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