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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 Use of Device Problem (1670); Insufficient Flow or Under Infusion (2182); Adverse Event Without Identified Device or Use Problem (2993); Insufficient Information (3190)
Patient Problem Low Blood Pressure/ Hypotension (1914)
Event Date 12/02/2018
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) regarding a patient receiving an unknown dose and concentration of baclofen via an implantable pump for intractable spasticity. It was reported the patient came into the emergency room with dropping, low blood pressure. The hcp reported they had already been ventilating the patient and may need to intubate the patient. The hcp reported that, per the patient¿s family, the patient¿s pump had been refilled a few days earlier (relative to the date of the report, (b)(6) 2018). It was indicated the symptoms occurred on (b)(6) 2018. It was reviewed the pump was not audibly alarming. It was reviewed the hcp would need a clinician programmer to check the pump settings. The hcp planned to follow-up with the patient¿s managing hcp and the hcp was transferred to the national answering service to have a representative paged. No further complications were reported or anticipated.
 
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
Additional information was received from the healthcare provider (hcp). It was reported the patient had missed their appointment and the pump was empty instead of just low. It was unknown how long the pump was empty. It was reported the patient was not hospitalized as a result of their symptoms. It was specified that the patient's pump was decreased to the lowest dose then restarted at a lower dose, 1/2 of the original dose.
 
Manufacturer Narrative
(b)(4). If information is provided in the future, a supplemental report will be issued.
 
Event Description
Additional information was received form the healthcare provider (hcp). It was reported the pump had been refilled three days prior to the patient going to the emergency room (on (b)(6) 2018). The hcp indicated the cause of the patient's hypotension had been determined. The cause of the hypotension was attributed to too high of a starting dose with the pump. The hcp stated the pump had been empty much longer than expected. Instead of 1-2 days, it was more likely weeks. Regarding other relevant factors that may have caused or contributed to the patient's hypotension and resultant treatment, the hcp stated the pump alarm was not accurate or a "dump" occurred. It was unknown if the patient had been hospitalized as a result of their symptoms. It was reported the patient was not intubated as a result of the event. Regarding other interventions taken as a result of the event, the hcp stated the patient's dosage of baclofen was lowered. The patient's status at the time of the report was provided as "good. ".
 
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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 Key8130863
MDR Text Key129297905
Report Number3004209178-2018-26853
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 health professional
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup,Followup
Report Date 02/01/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/04/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date10/28/2016
Device Model Number8637-20
Device Catalogue Number8637-20
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 Received01/31/2019
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured04/30/2015
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: 12/04/2018 Patient Sequence Number: 1
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