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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 8637-40
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Low Blood Pressure/ Hypotension (1914); Decreased Respiratory Rate (2485); Lethargy (2560)
Event Date 08/01/2021
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) via a healthcare provider (hcp) regarding a patient with a implantable infusion pump with lioresal (baclofen) concentration 2000 mcg/ml is and dose is 417. 5 mcg/day for intractable spasticity. It was reported that the reason for call was for assistance with decreasing a patient's flex dose. The rep stated that the patient is in icu and conference on the icu hcp who is ordering the decrease in the 24 hours dose. The icu physician states that he would like a 15% deduction of the basal rate from 12. 4 mcg to 10. 5 mcg and a 30% decrease for each step. The patient has three steps at 4 am, 12 pm, and 9 pm that are all 4 minutes and are a dose of 79. 9 mcg within 4 minutes. Technical services confirmed that he would like each step to drop to 55. 9 mcg and he agreed. The icu hcp ordered this decrease because the patient has been in icu with decrease respirations, decreased blood pressure, decreased respiratory rate, lethargic, and sleeping. The icu physician states that the patient's symptoms occur at near when the flex boluses are administered at 4 am, 12 pm, and 9 pm, so he suspects once they decrease the flex dose that her symptoms will alleviate. 24 hour dose went from 534. 8 mcg/day to 417. 6 mcg/day. Technical services assisted them in programming these changes.
 
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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
david gustafson
7000 central avenue ne rcw215
minneapolis, MN 55432
7635149628
MDR Report Key12284806
MDR Text Key265379329
Report Number3004209178-2021-11984
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 Non-Healthcare Professional
Type of Report Initial
Report Date 08/05/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/05/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date05/14/2021
Device Model Number8637-40
Device Catalogue Number8637-40
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/04/2021
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured11/14/2019
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: 08/05/2021 Patient Sequence Number: 1
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