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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 Problems No Audible Alarm (1019); Insufficient Flow or Under Infusion (2182)
Patient Problems Therapeutic Response, Decreased (2271); Sleep Dysfunction (2517)
Event Date 12/24/2019
Event Type  Injury  
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
Information was received from a manufacturer's representative (rep) regarding a patient who was receiving 10mg/ml morphine at 3. 214mg/day via an implantable infusion pump for spinal pain. It was reported that the low reservoir alarm went off on (b)(6) 2019 and the pump went empty on (b)(6) 2019. The patient saw the empty pump message on their patient programmer, but did not hear an alarm for the empty pump. The patient was in the hospital due to withdrawal symptoms, and wasn't able to sleep. The healthcare professional and patient insisted on replacing the pump due to it being empty for a couple of days. The 20ml pump was to be replaced with a 40ml pump. No further complications were reported.
 
Manufacturer Narrative
Correction: the initial report did not include hospitalization in error. (b)(4). If information is provided in the future, a supplemental report will be issued.
 
Event Description
Additional information was received via a company representative. The pump was replaced as per the physician's decision. The patient was fine now. It was noted that no further information was available at this time.
 
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Brand NameSYNCHROMED II
Type of DevicePUMP, 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 Key9559564
MDR Text Key183427294
Report Number3004209178-2020-00365
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
Reporter Occupation Non-Healthcare Professional
Type of Report Initial,Followup
Report Date 02/10/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/07/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date12/28/2019
Device Model Number8637-20
Device Catalogue Number8637-20
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received01/23/2020
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured07/10/2018
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: 01/07/2020 Patient Sequence Number: 1
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