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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC PUERTO RICO OPERATIONS CO. SYNCHROMED II; PUMP, INFUSION, IMPLANTED, PROGRAMMABLE

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MEDTRONIC PUERTO RICO OPERATIONS CO. SYNCHROMED II; PUMP, INFUSION, IMPLANTED, PROGRAMMABLE Back to Search Results
Model Number 8637-20
Device Problem Electromagnetic Interference (1194)
Patient Problem Fall (1848)
Event Date 06/08/2019
Event Type  Injury  
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
Information was received from the healthcare provider (hcp) regarding a patient receiving morphine (25 mg/ml at 9 mg/day) via an implantable infusion pump.The indication for use was non-malignant pain and failed back surgery syndrome.It was reported that the patient had fell and was admitted to the hospital.A magnetic resonance imaging (mri) was performed at 09.59 and a motor stall was seen at the initial interrogation more than 2 hours since the imaging was done.The caller stated that she did not hear any audible pump alarm.The pump was re-interrogated for a new set of logs and a motor stall recovery was confirmed.No further complications have been reported as a result of this event.
 
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Brand Name
SYNCHROMED II
Type of Device
PUMP, INFUSION, IMPLANTED, PROGRAMMABLE
Manufacturer (Section D)
MEDTRONIC PUERTO RICO OPERATIONS CO.
road 31, km. 24, hm 4
ceiba norte industrial park
juncos PR 00777
Manufacturer (Section G)
MEDTRONIC PUERTO RICO OPERATIONS CO.
road 31, km. 24, hm 4
ceiba norte industrial park
juncos PR 00777
Manufacturer Contact
lisa woodward clark
7000 central avenue ne rcw215
minneapolis, MN 55432
7635263920
MDR Report Key8691958
MDR Text Key147753885
Report Number3004209178-2019-11444
Device Sequence Number1
Product Code LKK
UDI-Device Identifier00643169508149
UDI-Public00643169508149
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 health professional
Reporter Occupation Other Health Care Professional
Remedial Action Notification
Type of Report Initial
Report Date 06/12/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date07/28/2018
Device Model Number8637-20
Device Catalogue Number8637-20
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 06/11/2019
Initial Date FDA Received06/12/2019
Date Device Manufactured02/07/2017
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Removal/Correction NumberZ-0591-2009
Patient Sequence Number1
Patient Outcome(s) Hospitalization;
Patient Age62 YR
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