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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC NEUROMODULATION PUMP, INFUSION, IMPLANTED, PROGRAMMABLE

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MEDTRONIC NEUROMODULATION PUMP, INFUSION, IMPLANTED, PROGRAMMABLE Back to Search Results
Model Number NEU_UNKNOWN_PUMP
Device Problems Unstable (1667); Device Displays Incorrect Message (2591); Torn Material (3024)
Patient Problems High Blood Pressure/ Hypertension (1908); Low Blood Pressure/ Hypotension (1914); Itching Sensation (1943); Pain (1994)
Event Date 02/01/2017
Event Type  malfunction  
Manufacturer Narrative
(b)(4) no longer applies. If information is provided in the future, a supplemental report will be issued.
 
Event Description
Additional information was received from a consumer (con). It was reported that the pump was empty. The patient was told she was not getting any morphine. The patient was at the hospital at this time. The patient said her blood pressure was going high and then dropping low due to pain. The patient had a kidney infection. 2 weeks after implant (unknown date) the pump had come loose and it was turning and flipping. Additional information was received from a consumer (con). It was reported that the patient was at the hospital and in a lot of pain as their pump did not have morphine in it and had not had morphine for two months. The patient was given percocet at the hospital and was reportedly itchy. The patient was reportedly experiencing blood pressure changes ("blood pressure shoots up and drops off") due to the pain. The patient had not found a managing physician as of yet. The patient noted that they were undergoing testing as the patient's kidneys were "small". The patient noted that their pump was turning and was now in their spine as the pump stitches had come loose.
 
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
Information was received from a consumer regarding a patient who was receiving an unknown drug (dose and concentration unknown) via an implantable pump. The consumer reported that the pump had not worked properly because he thought that since the end of february/beginning of march, the stitchings that hold the pump in place had come loose and because of this the pump moves all around in there. The patient had been experiencing pain and had been in and out of the hospital, before they came to (b)(6) , the consumer carried the patient twice to a hospital in (b)(6) and once in a hospital in (b)(6) where they currently were. The pain was reported to have begun 2 weeks prior to this report date and later it was reported that the pain begun at the end of february or beginning of march. There was no out of box failure reported. The patient did not have a health care professional as they just moved and patient service specialist sent a physician listing to the consumer so the patient could establish care with a new doctor in (b)(6). The consumer did not know the patients pump serial or model number but stated that the patient was implanted in february in (b)(6). It was further noted that the patient no longer had morphine in the pump but there was no mention of any symptoms/events specifically associated with the drug running out. The drug type, dose, or concentration for when the patient experienced the events reported in this call were unknown to the reporter. No further complications were reported.
 
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Type of DevicePUMP, INFUSION, IMPLANTED, PROGRAMMABLE
Manufacturer (Section D)
MEDTRONIC NEUROMODULATION
800 53rd ave ne
minneapolis MN 55421 1200
Manufacturer (Section G)
MEDTRONIC NEUROMODULATION
800 53rd ave ne
minneapolis MN 55421 1200
Manufacturer Contact
lisa woodward clark
7000 central avenue ne rcw215
minneapolis, MN 55432
7635263920
MDR Report Key6977660
MDR Text Key102718757
Report Number3007566237-2017-04555
Device Sequence Number1
Product Code LKK
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
P860004
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer
Reporter Occupation
Type of Report Initial,Followup
Report Date 11/22/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received10/25/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberNEU_UNKNOWN_PUMP
Device Catalogue NumberNEU_UNKNOWN_PUMP
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 Received10/27/2017
Was Device Evaluated by Manufacturer? No Answer Provided
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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