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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC MED REL MEDTRONIC PUERTO RICO PRIMEADVANCED; STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF
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MEDTRONIC MED REL MEDTRONIC PUERTO RICO PRIMEADVANCED; STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF Back to Search Results
Model Number 37702
Device Problems Energy Output Problem (1431); Battery Problem (2885); Device Operates Differently Than Expected (2913); Insufficient Information (3190)
Patient Problems Memory Loss/Impairment (1958); Pain (1994); Therapeutic Effects, Unexpected (2099); Anxiety (2328); Discomfort (2330); Malaise (2359); Depression (2361); No Known Impact Or Consequence To Patient (2692)
Event Type  malfunction  
Manufacturer Narrative
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
Information was received from the caretaker of a patient with an implantable neurostimulator (ins) for multiple back operations.It was reported that the patient's device did not seem to be working.It was indicated that the patient was now living in an assisted nursing home and she had not used the device for a while.It had not been checked ever since the patient was transferred to the facility.It was indicated that the patient was sick and had memory problems.No patient complication was reported as a result of the event.
 
Manufacturer Narrative
Patient codes have been removed.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
Additional information was received from the consumer reporting the patient has memory loss issues; the patient once turned the device off in 2015 which resulted in device eventually dying.On (b)(6) 2015, the patient was taken to the doctor and device was restarted without any issues.After that appointment, the patient had turned the device back off but the exact date was unknown.Sickness and memory loss was not related to the devices.Since the device was turned off, the sickness returned.Two weeks ago, patient was seen by a company representative (rep) and they turned the device back on without any issues.The cause of this event was due to the patient turning the device off.The ins was working fine but the patient keeps turning the device off every now and then; the patient was told not to do that and to leave the device on.
 
Manufacturer Narrative
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
If information is provided in the future, a supplemental report will be issued.
 
Event Description
Additional information received from the patient reported they had experienced ¿discomfort¿ as of (b)(6) 2017.No further information was reported; no further complications were reported or anticipated.
 
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
Information was reported that a patient¿s stimulation was on constantly and it was bothering her and making her uncomfortable.Patient requested for a manufacturer representative (rep) to come and shut the implant off.Patient stated she had ¿mental health issues¿.Patient had lost her programmer, but she had no interest in getting a replacement.She wanted the implant turned off and she was going to have it taken out.Patient stated she has an appointment with her doctor on monday.Patient requested the local rep to come and turn her device off.Additional information was reported that the patient still had not had their stimulation turned off and the patient was having a difficult time with depression and anxiety that was exacerbated by pain in her back.The stimulation was making it worse.Additional information received from the healthcare professional (hcp) reported that during a (b)(6) 2010 office visit the patient had low back pain and a myelogram and ct scan showed evidence of l3-l4 disc degeneration.The wound from the recent revision was well healed.On a (b)(6) 2011 office visit the patient had a recurrence of pain radiating from the lower back into the right buttock and was using the implant with some relief after an unrelated surgery.An examination found that there was right sciatic notch tenderness and her wounds from her surgery were well healed.An office visit on (b)(6) 2015 stated that the patient had stopped using her implant three years ago and had right sacroiliac joint block without relief of low back pain down the right lower extremity.A ct scan found postoperative changes from an unrelated fusion and the wound was well healed.
 
Manufacturer Narrative
Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.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.
 
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Brand Name
PRIMEADVANCED
Type of Device
STIMULATOR, 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
MDR Report Key6498339
MDR Text Key72987080
Report Number3004209178-2017-08423
Device Sequence Number1
Product Code LGW
Combination Product (y/n)N
PMA/PMN Number
P840001
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer,health professional
Type of Report Initial,Followup,Followup,Followup,Followup
Report Date 10/23/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/17/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date10/14/2010
Device Model Number37702
Device Catalogue Number37702
Was Device Available for Evaluation? No
Date Manufacturer Received10/23/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Weight93
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