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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); Improper or Incorrect Procedure or Method (2017); Insufficient Flow or Under Infusion (2182)
Patient Problems Bradycardia (1751); Fatigue (1849); Low Blood Pressure/ Hypotension (1914)
Event Date 04/01/2019
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 professional (hcp) via a company representative regarding a patient who was receiving clonidine 200 mcg/day (unknown concentration) via an implantable pump. Indication for use was non-malignant pain. The date of the event was approximately (b)(6) 2019. It was reported the patient was approximately two weeks late for a pump refill. The patient followed up at the hcp office on (b)(6) 2019 for a pump refill. The hcp attempted to refill the pump and had to stick the patient several times. The hcp felt like he had the needle in the reservoir. The hcp was unable to pull any fluid back, as the pump was dry. The hcp pushed the drug in and attempted to pull back during the refill a couple of times, 5 cc each and the drug did come back. The hcp continued to feel like he was in the reservoir. After filling the pump, the hcp pulled the needle out and again, felt like it had been in reservoir. The pump was programmed. The patient left the building and as she got into parking lot, started to feel tired. The patient went back to the hcp office. The patient¿s blood pressure and heart rate were low. At that time, it was believed that the pocket was filled and not the pump. Factors that may have led to the issue was the patient was obese, no weight given. An ambulance was called. The patient was transported to the hospital but did not have to be incubated. The patient was ¿doing okay¿ on (b)(6) 2019. The issue was resolved. Patient status was alive - no injury. Patient weight and medical history were asked and will not be made available. No further complications were reported.
 
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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 Key8594774
MDR Text Key144540676
Report Number3004209178-2019-09221
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
Remedial Action Notification
Type of Report Initial
Report Date 05/09/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/09/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date05/14/2019
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 Received05/08/2019
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured11/16/2017
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Removal/Correction NumberZ-1060-2011

Patient Treatment Data
Date Received: 05/09/2019 Patient Sequence Number: 1
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