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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 Insufficient Flow or Under Infusion (2182)
Patient Problems Dyspnea (1816); Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Event Date 03/16/2021
Event Type  malfunction  
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
Information was received from a healthcare professional (hcp) via a clinical study and a manufacturer representative (rep) regarding a patient receiving remodulin (unknown dose and concentration) via an implantable pump. It was reported there was a device malfunction where the expected residual volume was 9. 2 ml and the actual residual volume was 17. 9ml. The pump accuracy was 72% and the flow rate was outside the expected range. The patient reported no symptoms and there was no impact to the patient. There was no additional medical intervention required to prevent permanent injury or impairment and no action was taken. No assessment for product/therapy/procedure relatedness was performed. The patient's medical history included dyspnea / shortness of breath - on exertion, exercise intolerance, palpitations, orthopnea, congenital heart disease, hypertension, pulmonary hypertension (ph), syncope, due to unknown etiology, valve dysfunction, aortic, valve dysfunction, mitral, valve dysfunction, tricuspid, valve dysfunction, pulmonary, cor pulmonale, intrapulmonary shunting, renal dysfunction, not requiring dialysis, obesity, peripheral edema, sleep apnea, pneumonia, left upper lobe calcified granuloma, fibromyalgia, hysterectomy, back surgery, bacteremia (groshong catheter infection), dizziness, pre-syncope, jaw pain, headache, nausea, and chest pain. The event date was (b)(6) 2021. Additional information received from a rep indicated there was no resolution for this particular incident and no action was taken. In regards to the cause, it was noted it was unknown and was being investigated. No further complications were reported/anticipated.
 
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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 Key11708115
MDR Text Key247221287
Report Number3004209178-2021-06503
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,Followup,Followup,Followup
Report Date 10/04/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received04/22/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date05/14/2018
Device Model Number8637-40
Device Catalogue Number8637-40
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 Received09/23/2021
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured11/21/2016
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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