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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 Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Pain (1994)
Event Date 06/11/2015
Event Type  Injury  
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
Additional information was received from the healthcare professional. It was reported that the system was explanted due to the painful stimulation. It was noted that the patient's baseline weight was (b)(6) kilograms.
 
Manufacturer Narrative
Other applicable components are: product id: 977a260, serial# (b)(4), implanted: (b)(6) 2014, explanted: (b)(6) 2017, product type: lead. Product id: 977a260, serial# (b)(4), implanted: (b)(6) 2014, explanted: (b)(6) 2017, product type: lead. If information is provided in the future, a supplemental report will be issued.
 
Event Description
Information was received from a healthcare professional of a clinical study regarding a patient with an implantable neurostimulator (ins) for non-malignant pain. It was reported that the patient had painful stimulation. The outcome was unresolved with no further action planned. Interventions included suspending therapy. The patient reported that higher levels of stimulation cause pain. The patient had stopped using the stimulator. The etiology was noted as related to the device or therapy and not related to the implant procedure. The etiology was noted as not due to programming. Additional information was received from the hcp of a clinical study reporting that the entire system was explanted on (b)(6) 2017 and not replaced. The outcome was resolved without sequelae on (b)(6) 2017. No further complications were reported or 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 Key7151738
MDR Text Key103714667
Report Number3004209178-2017-26740
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 01/16/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/28/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date07/14/2015
Device Model Number97714
Device Catalogue Number97714
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 Received01/09/2018
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured08/26/2014
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: 12/28/2017 Patient Sequence Number: 1
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