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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 Fever (1858); High Blood Pressure/ Hypertension (1908); Low Blood Pressure/ Hypotension (1914); Unspecified Infection (1930)
Event Date 09/27/2021
Event Type  Injury  
Manufacturer Narrative
Concomitant medical products: product id 8780, lot# serial# (b)(4), implanted: (b)(6) 2018, product type: catheter. Other relevant device(s) are: product id: 8780, serial/lot #: (b)(4), ubd: 22-aug-2015, udi#: (b)(4). If information is provided in the future, a supplemental report will be issued.
 
Event Description
Information was received from a company representative (rep) via a healthcare provider (hcp) regarding a patient with an implantable infusion pump receiving baclofen (loiresal) with a concentration of 2000 mcg/ml and a dose of 800 mcg/day for intractable spasticity and head/brain injury. It was mentioned hcp stated patient had spinal surgery last week and the patient had tachycardia, agitation and hypertension post surgery. Hcp stated the patient has been hospitalized since the surgery. Hcp stated on friday of last week they did a cap aspiration to check the catheter and were able to aspirate freely from the cap and re-primed the tcv. Hcp stated patient had some hypotension post aspiration and since he has had a fever, hypotension and hypertension. Hcp stated today they attempted a cap dye study and were only able to aspirate 0. 8ml of fluid. Hcp was wondering about re-priming now. Hcp stated they are going to rule out infection also.
 
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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
glen belmer
7000 central avenue ne rcw215
minneapolis, MN 55432
6122713209
MDR Report Key12666878
MDR Text Key277464953
Report Number3004209178-2021-15624
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 10/20/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/20/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date01/28/2022
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 Received10/06/2021
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured08/05/2020
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: 10/20/2021 Patient Sequence Number: 1
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