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U.S. Department of Health and Human Services

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

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MEDTRONIC MED REL MEDTRONIC PUERTO RICO RESTORE ULTRA STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF Back to Search Results
Model Number 37712
Device Problems Battery Problem (2885); Charging Problem (2892)
Patient Problems Pain (1994); Therapeutic Effects, Unexpected (2099); Therapeutic Response, Decreased (2271); Malaise (2359)
Event Date 06/30/2010
Event Type  Injury  
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
Additional information was received from healthcare professional of a clinical study. It was stated that on (b)(6) 2015, patient reported the device had been off as the patient programmer had malfunctioned and required return to manufacturer. Specific issue with programmer was no documented. Patient has had the device off as a result of malfunction. On (b)(6) 2015 patient reported the difficulty was with the charging system and reported they will contact manufacturer for assistance. On (b)(6) 2015, patient's device was on and was able to be reprogrammed by manufacturer representative. The actions/intervention taken were not recorded. The device was reprogrammed after therapy suspension for 3 months. It was unable to achieve improved coverage/pain relief with programming. On (b)(6) 2015, patient reported minimal relief with stimulation/decreased therapeutic effect, patient utilized the device often with minimal relief. On (b)(6) 2015, patient reported no relief with device and requested an explant. Patient was encouraged to schedule reprogramming session. On (b)(6) 2016. Manufacturer representative confirmed patient's device was permanently depleted, unable to recharge and requiring replacement. The entire device system was explanted, but not replaced, on (b)(6) 2016. No further complications were reported as a result of this event.
 
Manufacturer Narrative
In manufacturer's report (mfr) # 3004209178-2018-10883, it was reported that there were high impedances and the patient had their system explanted. It was corrected by the healthcare provider that the high impedances were reported in error and the system explant was previously reported. Additional review indicates the information related to the system explant pertains this mfr # 3004209178-2016-26197; any additional information related to the system explant will be reported under this mfr. If information is provided in the future, a supplemental report will be issued.
 
Manufacturer Narrative
Product id 37752 lot# (b)(4) implanted: explanted: product type recharger product id 37754 lot# serial# (b)(4) implanted: explanted: product type recharger product id 3778-60 lot# (b)(4) implanted: (b)(6)2010 explanted: (b)(6)2016 product type lead product id 3778-60 lot# (b)(4) implanted: (b)(6)2010 explanted: (b)(6)2016 product type lead product id 37743 lot# (b)(4) implanted: explanted: product type programmer, patient product id 37752 lot# (b)(4) implanted: explanted: product type recharger product id 37743 lot# (b)(4) : product type programmer if information is provided in the future, a supplemental report will be issued.
 
Event Description
Additional information from the healthcare professional (hcp) on august 5th reported the patient charging system malfunction. Additional information from the hcp on august 7th reported the recharge process was related to subject non-compliance, the patient chose not to recharge. There were no further complications that have been reported as a result of this event.
 
Event Description
It was reported that the implantable neurostimulator recharger (insr) was not working. There was a communication problem reported. The patient was advised to place the insr antenna over the implant then press the start charge button. The patient was seeing the reposition antenna screen. They had been seeing that screen for about a month. The last time the patient was able to charge the implant was about a month and a half prior. The patient had been really sick and the device had never been effective. Information regarding if the patient still had concerns with their device or therapy has been requested. Additional information was received from a health care provider (hcp) in a clinical study. It was reported that there was a loss of pain relief.
 
Manufacturer Narrative
Upon additional review, it was determined that the most appropriate date was (b)(4) 2016. 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.
 
Manufacturer Narrative
Device analysis for ins (b)(4) revealed no significant anomaly. The ins battery had reduced capacity due to overdischarge. The ins was received with no telemetry. According to the trace report obtained from the ins after pmr recovery, the total recharge count is 131. The last recorded recharge session performed while the device was implanted occurred on (b)(6) 2000. The device was recharged for 1 hour 55 minutes and the battery charged from 3. 710v to 3. 995v. The battery discharged to the lock mode on (b)(6) 2000. Testing of the recharge function of this ins found it to be functioning normally. The ins was placed in a body temperature oven with approximately 1cm of space between the ins and the charger antenna. A normal recharge started automatically during a physician mode recharge. The recharger had full coupling and the ins recharged for 2 hours 43 minutes to an end voltage of 3. 895v. Device analysis for lead (b)(4) revealed the body conductor was broken at the titan anchor site.
 
Manufacturer Narrative
(b)(4).
 
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Brand NameRESTORE ULTRA
Type of DeviceSTIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF
Manufacturer (Section D)
MEDTRONIC MED REL MEDTRONIC PUERTO RICO
ceiba norte industrial park, r
juncos PR 00777
Manufacturer (Section G)
MEDTRONIC MED REL MEDTRONIC PUERTO RICO
ceiba norte industrial park, r
juncos PR 00777
Manufacturer Contact
diane wolf
7000 central avenue ne rcw215
minneapolis, MN 55432
7635263987
MDR Report Key6165926
MDR Text Key101643735
Report Number3004209178-2016-26197
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,health professional
Reporter Occupation
Type of Report Initial,Followup,Followup,Followup,Followup
Report Date 08/29/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/12/2016
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date03/14/2011
Device Model Number37712
Device Catalogue Number37712
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/01/2016
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/05/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured04/20/2010
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: 12/12/2016 Patient Sequence Number: 1
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