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U.S. Department of Health and Human Services

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

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MEDTRONIC NEUROMODULATION SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE Back to Search Results
Model Number 8637
Device Problem Device Operates Differently Than Expected (2913)
Patient Problems Abdominal Pain (1685); Fall (1848)
Event Date 10/09/2017
Event Type  malfunction  
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
Additional information was received from the patient. It was reported that the patient stated that the pump did not work. No further complications were reported.
 
Event Description
Information was received from a patient who was receiving an unknown drug at an unknown concentration at a dose of "7. 5," unknown frequency] via intrathecal drug delivery pump for an unknown indication for use. It was reported that the patient had begun her trial for her pain pump the day before this report and she would be on it for 3 days. The patient reported that the night before this report, her legs were doing good with the pump, but in the midsection she was "hurting so bad". The patient reported that because of this, she went to the hospital and was given a dilaudid shot. The patient also reported that she went home the same day and fell down. The patient reported that the reason for her call was because the emergency room doctor at the hospital turned her pump off and she needed help turning her pump back on. The patient later on in the call corrected herself, stating that she did not think he turned it off all the way. The following troubleshooting was reported: the patient said she was reading from some type of external device that was given to her by a manufacturer representative that led her to believe that the pump wasn't turned "all the way off. " it was reported that the patient service specialist (pss) asked the patient what her d rug information was (type, dose, and concentration). The patient said she did not know the type or concentration, but responded that "7. 5" was her dose. Pss asked if she knew the unit for her dose and the patient said she did not know. No further complications were reported.  .
 
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Brand NameSYNCHROMED II
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 Key6948873
MDR Text Key101656955
Report Number3007566237-2017-04391
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 10/16/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received10/13/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model Number8637
Device Catalogue Number8637
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 Received10/16/2017
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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