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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 Problem Overheating of Device (1437)
Patient Problems Burn(s) (1757); Skin Inflammation (2443)
Event Date 06/01/2017
Event Type  malfunction  
Manufacturer Narrative
Concomitant medical products: product id: 977a260, serial# (b)(4), implanted: (b)(6) 2015, product type: lead. Product id: 977a260, serial# (b)(4), implanted: (b)(6) 2015, product type: lead. Information references the main component of the system. Other relevant device(s) are: product id: 977a260, serial/lot #: (b)(4), ubd: (b)(6) 2019, udi#: (b)(4); product id: 977a260, serial/lot #: (b)(4), ubd: (b)(6) 2019, udi#: (b)(4). 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. It was reported that every time the patient turned stimulation on it "literally burned" the patient. The patient was doing an mri to see if the prong slipped off or something. This started happening (b)(6) 2017. It was reported that they had little blister appeared and left a hole once it burst. The patient was also diabetic so they did want it to keep happening because the patient worries about infections. The burning occurred where the lead was at their mid thoracic area. The patient did not have a trauma, fall, or emi. 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 Key7537622
MDR Text Key109043605
Report Number3004209178-2018-11653
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 05/23/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received05/23/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date08/14/2016
Device Model Number97714
Device Catalogue Number97714
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 Received05/21/2018
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured09/25/2015
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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