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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC MED REL MEDTRONIC PUERTO RICO RESTORE ADVANCED STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF

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MEDTRONIC MED REL MEDTRONIC PUERTO RICO RESTORE ADVANCED STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF Back to Search Results
Model Number 37713
Device Problems Energy Output To Patient Tissue Incorrect (1209); Positioning Problem (3009)
Patient Problems Bruise/Contusion (1754); Nerve Damage (1979); Therapeutic Effects, Unexpected (2099)
Event Date 03/12/2009
Event Type  Injury  
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: 39565-30, serial# (b)(4), implanted: (b)(6) 2009, product type: lead. Product id: 3708140, serial# (b)(4), implanted: (b)(6) 2009, product type: extension. Product id: 3708140, serial# (b)(4), implanted: (b)(6) 2009, product type: extension. Product id: 37743, serial# (b)(4), implanted: (b)(6) 2009, product type: programmer, patient. Product id: 37752, serial# (b)(4), implanted: (b)(6) 2009, product type: recharger. 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
A patient reported that following implantable neurostimulator (ins) replacement, the stimulator was not covering pain coming from toes. The patient stated that the manufacturer representative had not been able to program it to take care of the pain coming from toes. The stimulation was only going from the waist to the ankles. The patient stated there was not enough tissue to hold the implant in and so during surgery they had to do an "upside down pocket. " it was also reported that the patient had the ins on but they could not feel stimulation due to low setting. The patient increased setting while on the phone and reported feeling stimulation. Patient later inquired if she should still feel residual stimulation after her stimulation is turned off. It was reviewed that it was possible to have some residual stimulation, but not necessarily for an extended period of time. It turned out the patient still had stimulation on, though the setting was at 0. 0 amplitude. The patient could still feel stimulation. The patient was able to turn stimulation off and not feel stimulation. Patient also reported a bruised rib cage as a result of the replacement surgery. Additional information was received from the patient. The patient reported that the doctor nicked a nerve.
 
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Brand NameRESTORE ADVANCED
Type of DeviceSTIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF
Manufacturer (Section D)
MEDTRONIC MED REL MEDTRONIC PUERTO RICO
road 31, km. 24, hm 4
ceiba norte industrial park
juncos PR 00777
Manufacturer (Section G)
MEDTRONIC MED REL MEDTRONIC PUERTO RICO
road 31, km. 24, hm 4
ceiba norte industrial park
juncos PR 00777
Manufacturer Contact
lisa clark
7000 central avenue ne rcw215
minneapolis, MN 55432
7635263920
MDR Report Key6325514
MDR Text Key102517243
Report Number3004209178-2017-03673
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 02/13/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/13/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date02/28/2010
Device Model Number37713
Device Catalogue Number37713
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 Received02/08/2017
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured01/29/2009
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: 02/13/2017 Patient Sequence Number: 1
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