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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 Cellulitis (1768); High Blood Pressure/ Hypertension (1908); Unspecified Infection (1930); Nausea (1970); Rash (2033); Vomiting (2144)
Event Date 01/05/2022
Event Type  Injury  
Event Description
Information was received from a healthcare professional (hcp) via a clinical study regarding a patient receiving unknown drug via an implantable pump. It was reported the patient was experiencing rash in the body and high blood pressure, nausea, cellulitis, hypokalemia and vomiting due to excessive gastrointestinal loss of potassium after the it replacement surgery on (b)(6) 2022. The patient was admitted to the emergency department and given antibiotics drug. It was indicated the event was the result of infections. The issue resolved with sequelae, on (b)(6) 2022.
 
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
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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 Key13453348
MDR Text Key285637862
Report Number3004209178-2022-01632
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 Study,Company Representative
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 06/08/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/04/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model Number8637-40
Device Catalogue Number8637-40
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received06/07/2022
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured11/09/2021
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: 02/04/2022 Patient Sequence Number: 1
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