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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 Problems Insufficient Flow or Under Infusion (2182); Application Program Problem (2880)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 06/24/2020
Event Type  Injury  
Manufacturer Narrative
Other relevant device(s) are: product id: 8780, serial#: (b)(4), implanted: (b)(6) 2014, product type: catheter; product id: 8870, product type: software. If information is provided in the future, a supplemental report will be issued.
 
Event Description
Information was received from a healthcare provider who also informed a manufacturer's representative (rep) regarding a patient who was receiving 5 mg/ml of morphine at 2. 4977 mg/day via an implantable pump for non-malignant pain and chronic low back pain. On (b)(6) 2020, it was reported that a volume discrepancy was observed during a refill. The expected reservoir volume was 2. 5 ml but the hcp pulled back 34 ml. The hcp spoke with their rep who speculated that it was likely a catheter issue. The hcp removed all the medication from the pump and were orally managing the patient. The hcp had not done any other programming on the pump and had no plans to. The patient inquired about how to end the session in their programmer before transferring the report to the computer the hcp wanted to keep the information on the report as it showed the expected volume that they were supposed to pull back during the refill. The hcp tried to print the report using their old programmer as well, but they were unable to. No symptoms were reported. 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
david gustafson
7000 central avenue ne rcw215
minneapolis, MN 55432
7635149628
MDR Report Key10200534
MDR Text Key196605384
Report Number3004209178-2020-11130
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
Report Date 07/06/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/26/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date05/28/2016
Device Model Number8637-40
Device Catalogue Number8637-40
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/01/2020
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured12/03/2014
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: 06/26/2020 Patient Sequence Number: 1
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