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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 Dyspnea (1816); Muscular Rigidity (1968); Nerve Damage (1979); Chest Tightness/Pressure (2463)
Event Date 08/23/2018
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 provider (hcp) of a clinical study (sdy) regarding a patient with an implantable neurostimulator (ins) for non-malignant pain. It was reported that the patient was experiencing left shoulder and neck tightness. Sometimes in flares, they would present chest tightness and shortness of breath with the ins active. Interventions included reprogramming of the device. The etiology of the event was noted to be possibly related to the device or therapy, not related to the implant procedure, and due to programming/stimulation. The outcome of the event was noted as resolved without sequelae. On 2018-09-29, it was reported that the patient had chest tightness and a shortness of breath. They presented with left shoulder and neck tightness when they had the stimulator on all the time. On 2018-10-22, they reported that the patient had brachial plexopathy. It was noted that the intensity of the symptoms waxed and waned and, on good days, they were able to turn the device off and tolerate sitting at their desk. No further complications were reported or anticipated.
 
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
Additional information was received from a healthcare professional (hcp) via a manufacturer representative. It was reported that the event was related to the device/therapy and the cause of the brachial plexopathy was not determined. Reprogramming was done to resolve the brachial plexopathy; however, it was unclear if it had been resolved. 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 Key8047335
MDR Text Key126438807
Report Number3004209178-2018-24901
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 health professional,study
Reporter Occupation
Type of Report Initial,Followup
Report Date 12/21/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/07/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date02/14/2018
Device Model Number97712
Device Catalogue Number97712
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 Received12/17/2018
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured03/27/2017
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: 11/07/2018 Patient Sequence Number: 1
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