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U.S. Department of Health and Human Services

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

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MEDTRONIC MED REL MEDTRONIC PUERTO RICO RESTORE SENSOR STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF Back to Search Results
Model Number 37714
Device Problems High impedance (1291); Unintended Collision (1429); Improper or Incorrect Procedure or Method (2017); Battery Problem (2885); Charging Problem (2892); Insufficient Information (3190)
Patient Problems Chest Pain (1776); Pain (1994); Injury (2348)
Event Type  Injury  
Manufacturer Narrative
Concomitant medical products: product id: 3778-75, serial#: (b)(4), implanted: (b)(6) 2013, product type: lead. Product id: 3778-75, serial#: (b)(4), implanted: (b)(6) 2013, product type: lead. Other relevant device(s) are: product id: 3778-75, serial/lot #: (b)(4), ubd: 24-apr-2017, udi#: (b)(4). Product id: 3778-75, serial/lot #: (b)(4), ubd: 24-apr-2017, udi#: (b)(4). If information is provided in the future, a supplemental report will be issued.
 
Event Description
Information was received from a consumer via manufacturing representative (rep) regarding a patient with an implantable neurostimulator (ins). It was reported that since the patient device was jump started, it has gone dead for the 4th time at that. It was reported that patient fell and lead pain. In addition patient had a seizure and injured themselves a couple weeks ago and they are having unusual pain where their leads are, as well as their chest wall under their arms. The pain varies with angle. Patient wanted to be certain one or both leads did not slip, as well as discuss replacing their neurostimulator. Patient will be at the health care professional (hcp) office on (b)(6) 2018 for an existing appointment. Rep reported that patient device was in over discharge state and patient has seizure. Rep will meet with patient on (b)(6) 2018. The issue has not been resolved at the time of this report. No surgical intervention occurred. Unknown if intervention will occur. Patient is alive with no injury.
 
Manufacturer Narrative
Other applicable components are: product id: 3778-75, serial# (b)(4), implanted: (b)(6) 2013, product: type lead. Product id: 3778-75, serial# (b)(4), implanted: (b)(6) 2013, product: type lead. If information is provided in the future, a supplemental report will be issued.
 
Event Description
Additional information received from a manufacturer's representative. It was reported that the patient's ins was overdischarged and the physician was planning on replacing the ins and potentially the leads to give the patient "fully" body mri capabilities. The physician didn't note an issue with the upper incision site and the lead did not slip. The chest pain or rib pain was their chronic pain which resulted from a chest tube "place" years ago- this was the pain the stimulator was implanted to help. The ins was overdischarged at least 3 times and the patient didn't want to attempt to recharge the ins. No further complications reported.
 
Manufacturer Narrative
High impedances occurred with 1 lead (serial #(b)(4)) and 2 implantable neurostimulators. Information regarding the other system implanted is: product id: 97715, serial# (b)(4), implanted: (b)(6) 2018, product type: implantable neurostimulator. Continuation of concomitant medical products: product id: 3778-75, serial# (b)(4), implanted: (b)(6) 2013, product type: lead; product id: 3778-75, serial# (b)(4), implanted: (b)(6) 2013, product type: lead; product id: 97715, serial# (b)(4), implanted: (b)(6) 2018, product type: implantable neurostimulator. If information is provided in the future, a supplemental report will be issued.
 
Event Description
Additional information was received from a consumer, via a manufacturer representative (rep). It was reported that the ins was overdischarged multiple times so the patient wanted a new device. The patient experienced multiple hospital stays a year and ended up not being able to recharge the ins. The rep said that impedances were over 40,000 on contacts 3 and 4. It was noted that the patient had multiple falls due to a seizure disorder. The rep tested impedances multiple times with the same results; the rep said they were unsure if impedances were out of range before surgery because the ins was overdischarged. The healthcare professional was ok leaving impedances on the lead alone. The rep reprogrammed on the other lead and the patient was getting great coverage. It was noted that the issue was resolved at the time of the report. No further complications were reported/anticipated.
 
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Brand NameRESTORE SENSOR
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 woodward clark
7000 central avenue ne rcw215
minneapolis, MN 55432
7635263920
MDR Report Key7970826
MDR Text Key124128398
Report Number3004209178-2018-23171
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 company representative,consum
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 12/10/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/16/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date01/28/2014
Device Model Number37714
Device Catalogue Number37714
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received12/06/2018
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured03/07/2013
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: 10/16/2018 Patient Sequence Number: 1
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