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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, IMPLANTED (PAIN RELIEF)
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MEDTRONIC PUERTO RICO OPERATIONS CO. SURESCAN; STIMULATOR, SPINAL-CORD, IMPLANTED (PAIN RELIEF) Back to Search Results
Model Number 97714
Device Problems Unintended Collision (1429); Therapy Delivered to Incorrect Body Area (1508); Device Operates Differently Than Expected (2913)
Patient Problems Undesired Nerve Stimulation (1980); Therapeutic Effects, Unexpected (2099)
Event Date 03/03/2015
Event Type  malfunction  
Manufacturer Narrative
Concomitant medical products: product id 97740, serial# (b)(4), product type: programmer, patient; product id 9 7754, serial# (b)(4), product type: recharger; product id 977a160, serial# (b)(4), implanted: (b)(6) 2015, product type: lead; product id 977a160, serial# (b)(4), implanted: (b)(6) 2015, product type: lead.(b)(4).
 
Event Description
It was reported that there was stimulation in the wrong location.The patient was in a car accident.The patient's stimulation did not reach the area that she would have liked it to; behind her right leg and to the side.The patient was going to have a mri to check her hip, thigh and low back where the stimulator was located.The healthcare provider wanted to see the placement of the device and make sure he wasn't missing anything.The patient was having an mri done and was working with her doctor to try and resolve her issue.The patient had also tried reprogramming but had not been successful at getting the stimulation where she would have like it.Upon follow-up there were no result of the mri performed.It was unclear if the patient had an mri or if there were no results.Actions and interventions taken to resolve the stimulation issue not in the desired location was sensor reprogramming that was scheduled.The cause of the stimulation issue was unknown.No outcome was reported if additional information is received a follow-up report will be sent.
 
Manufacturer Narrative
(b)(4).
 
Event Description
Additional information received reported that the stimulation did not reach one spot on the back of the patient's thigh and they wanted to figure out why.The patient said that it was horrible and she wanted to punch the wall when she moved in bed.The reported symptom was pain in the patient's leg.
 
Event Description
Additional information received reported that the stimulation did not reach one spot on the back of the patient's thigh and they wanted to figure out why.The patient said that it was horrible and she wanted to punch the wall when she moved in bed.
 
Manufacturer Narrative
(b)(4).
 
Event Description
The reason for the device was that the patient was in a car accident.
 
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Brand Name
SURESCAN
Type of Device
STIMULATOR, SPINAL-CORD, IMPLANTED (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 NEUROMODULATION
7000 central avenue ne rcw215
minneapolis MN 55432
Manufacturer Contact
diane wolf
7000 central avenue ne rcw215
minneapolis, MN 55432
7635263987
MDR Report Key4920343
MDR Text Key22458949
Report Number3004209178-2015-13582
Device Sequence Number1
Product Code GZB
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,health professional
Reporter Occupation Other
Report Date 06/29/2015
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/16/2015
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date12/28/2015
Device Model Number97714
Device Catalogue Number97714
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Date Manufacturer Received07/27/2015
Date Device Manufactured01/29/2015
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Age00062 YR
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