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U.S. Department of Health and Human Services

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

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MEDTRONIC PUERTO RICO OPERATIONS CO. RESTORE SENSOR STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF Back to Search Results
Model Number 37714
Device Problems Migration or Expulsion of Device (1395); Unintended Collision (1429); Overheating of Device (1437); Therapy Delivered to Incorrect Body Area (1508)
Patient Problems Abdominal Pain (1685); Bruise/Contusion (1754); Erythema (1840); Fall (1848); Headache (1880); High Blood Pressure/ Hypertension (1908); Device Overstimulation of Tissue (1991); Pain (1994); Burning Sensation (2146); Anxiety (2328); Complaint, Ill-Defined (2331); Malaise (2359)
Event Date 12/01/2015
Event Type  Injury  
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Manufacturer Narrative
Section d information references the main component of the system and other applicable components are: product id: 3888-56, lot# va0mcdw, implanted: (b)(6) 2014, product type: lead. Product id: 3708220, serial# (b)(4), implanted: (b)(6) 2014, product type: extension. Product id: 3708220, serial# (b)(4), implanted: (b)(6) 2014, product type: extension. 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 they were in a car accident in (b)(6) 2015, and injured her back and tailbone. The patient stated that the airbag from the accident dented the implantable neurostimulator (ins) battery pack in her chest. The patient was bruised in the area where the airbag struck the patient and noted that her skin looked black. The patient stated that prior to the accident they could have stimulation at 1. 25 and stated that after the accident she cannot have stimulation above. 25 or. 30 because it is painful. The patient reported that when she recharges her ins, the lead wires in her head ¿burn her¿ and that her face turns red. The patient has to turn stimulation off because her head hurts so badly since the accident. The patient stated that she used to charge her ins every week but now she dreads charging because of the pain she feels in her head. The patient stated that the representative was notified about the pain in her head from recharging during her reprogramming appointment on (b)(6) 2016. The patient stated she has consulted with the representative and physician multiple times about pain. Her doctor has checked the ins and leads and told her that the leads are fine. The patient stated an x-ray had not been done to check lead wire position. The patient reported she got really sick in 2016 with stomach issues. They are not sure what caused the illness and constant headache. The patient states she still has migraines. The patient reported they have tried to reprogram but it has not helped the patient pain in the patient¿s head. The patient states the stimulation is not hitting the right spot since (b)(6) 2015. The back of her head is still hurting and states it ¿pinches¿ when it rains. The patient further stated that she falls and her legs give out on her since the accident in (b)(6) 2015. The patient reported a lead wire was sticking out of her head in 2016. The doctor covering for her physician put a band aid over it and told the patient wait until her doctor returned. The patient stated it hurt and she ended up going to the hospital to have the lead repaired. The patient was not eating and was sick from pain medication and scared to death when she had to go in and have it fixed. The patient reported that her back started to hurt in 2016, about a month after the accident. The patient states her tailbone is the main source of her pain. The patient stated that all the leads are behind her right ear. She has a lot of pain in her temple because of where the leads are placed. The patient reported it is irritating to her and pain goes in to her jaw. The patient will not go into the dentist because she cannot bear someone touching her face. The patient was redirected their healthcare provider. No further complications were reported. The indication for implant was non-malignant pain. Additional information was received from the manufacturer representative. The representative met with the patient in clinic on (b)(6) 2017. It was reported that the representative was aware that the patient had been in a car accident and was asked to reprogram the patient to help with the patient¿s needs. Per the healthcare provider¿s guidance, the patient¿s programs were changed. The representative was not aware of a change in recharging following the car accident. No further complications were reported/anticipated.
 
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
Additional information was received from a consumer on 2017-06-12. Patient weight was reported to be around (b)(6). Steps taken were to show the patient more information on how to charge the wires with ¿stimulation¿ off (a symbol of the letter ¿v¿ with a square around it was written into the original document. This was interpreted as meaning stimulation. ). The patient reported that they had the neurostimulator in their head for pain that was from an injury on (b)(6) 2004. It was noted that the patient¿s health care professional (hcp) had been out of the office for a month, so they called the manufacturer. The patient had been in an automobile accident on (b)(6) 2015 and was getting treatment on their tailbone. The patient had a cat scan and the hcp wanted an mri. When the patient called they were told that they would only have an mri for their head. It was noted that the patient had told the manufacturer over the phone that their wires were in their head. The patient reported that they eventually found out from their hcp that the patient could not have an mri at all and if they had they would have tissue damage and more pain. The leads were rechecked and everything was working great. It was also explained that the patient could have an x-ray. It was also shown how to take off ¿stimulation¿ (a symbol of the letter ¿v¿ with a square around it was written into the original document. This was interpreted as meaning stimulation. ) on the charger so that the patient did not get ¿a flushed feeling etc. ¿ it was reported that the patient had numerous health problems. The patient provided their notes for the call they made to the manufacturer on (b)(6) 2017. During the call mri eligibility was reviewed, it was noted that an x-ray should be performed as the positioning of the leads may move from the correct spot and if they did not know then an x-ray should be done. It was reported that when the patient charged their wires it burned in their head. The hot w ires hurt, their blood pressure went up, and their face became flushed. The patient reported that they were told that it could be a charger mark. It was reported that the wires did not charge like they did before the accident. It was reported that it was saying 130 now 25. The patient had been in contact with their hcp office. On (b)(6) 2017, the patient had met the hcp and manufacturer representative in the office but no mri was performed. No further complications were reported.
 
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Brand NameRESTORE SENSOR
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 Key6570988
MDR Text Key102488922
Report Number3004209178-2017-10421
Device Sequence Number1
Product Code LGW
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 06/22/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/16/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date06/14/2015
Device Model Number37714
Device Catalogue Number37714
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 Received06/12/2017
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured07/15/2014
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: 05/16/2017 Patient Sequence Number: 1
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