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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 Problems Fluid Leak (1250); Insufficient Information (3190)
Patient Problems Fatigue (1849); Rash (2033); Insufficient Information (4580)
Event Type  Injury  
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
Information was received from a healthcare provider (hcp) via a company representative regarding an unknown patient receiving an unknown medication via an implanted pump. It was reported that the patient¿s pump malfunctioned. Per the hcp, the patient came in for a refill (date unknown). They filled the pump and the patient began to have a ¿systemic reaction¿ and had a rash near the pump site in the soft tissues. The hcp sent the patient home and that night the patient felt drugged, was falling asleep, and was barely able to stay awake. The hcp brought the patient back in and took out the medication and put contrast in and realized that the contrast was ¿spraying out of the port¿. The ¿connector port¿ was leaking and he believed that the pump was ¿throwing a bolus by itself¿ and stated that he did not have flex boluses programmed. Per the hcp, the pump was replaced. The hcp indicated that the event had been previously reported; however, no report could be found. The hcp was contacted to obtain the identifying information for the pump and patient involved; however, the hcp could not provide any additional information regarding the pump or the patient and stated that they had no further information to provide regarding the event.
 
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Brand NameSYNCHROMED II
Type of DevicePUMP, INFUSION, IMPLANTED, PROGRAMMABLE
Manufacturer (Section D)
MEDTRONIC NEUROMODULATION
7000 central ave ne
minneapolis MN 55432
Manufacturer (Section G)
MEDTRONIC NEUROMODULATION
7000 central ave ne
minneapolis MN 55432
Manufacturer Contact
david gustafson
7000 central avenue ne rcw215
minneapolis, MN 55432
7635149628
MDR Report Key11875003
MDR Text Key252342348
Report Number2182207-2021-00886
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 company representative,health
Reporter Occupation
Type of Report Initial
Report Date 05/25/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/25/2021
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? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received04/30/2021
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

Patient Treatment Data
Date Received: 05/25/2021 Patient Sequence Number: 1
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