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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 Problems Therapy Delivered to Incorrect Body Area (1508); Device Or Device Fragments Location Unknown (2590); Malposition of Device (2616); Device Operates Differently Than Expected (2913)
Patient Problems Undesired Nerve Stimulation (1980); Malaise (2359)
Event Date 11/10/2015
Event Type  malfunction  
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Manufacturer Narrative
The main component of the system and other applicable components are: 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. A good faith effort will be made to obtain the applicable information relevant to the report. If information is provided in the future, a supplemental report will be issued.
 
Event Description
Information was received from a family member of a patient who was implanted with a neurostimulator for spinal pain and failed back surgery syndrome. It was reported on (b)(6) 2016 that the patient¿s implantable neurostimulator (ins) didn¿t work and that the healthcare professional (hcp) put the leads in the wrong place. It was noted that during the implant, the patient was on their stomach (sedated) and felt the stimulation ¿good¿. But once they got up and the sedation wore off, the stimulation was on the wrong side and they did not feel any relief. The manufacturer representative worked hard to try to reprogram the device to get stimulation to the correct side but was not able to. The patient was still implanted with the device but was not using it. The patient was to have an mri and the family member was able to program it into the mri mode. Additional information was received from a family member of the patient on (b)(6) 2016 that reported that the device never worked since the day of implant and they put the leads in the wrong place. The patient has since been ill and now needs a mri. Since the patient has been ill, he cannot get it out. It has been in so long and it is not being used. The health care provider said that he could not do anything to correct it.
 
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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
diane wolf
7000 central avenue ne rcw215
minneapolis, MN 55432
7635263987
MDR Report Key6150979
MDR Text Key102432248
Report Number3004209178-2016-25318
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 12/06/2016
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/07/2016
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date12/28/2016
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 Received12/05/2016
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured07/06/2015
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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