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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 Problem Contamination (1120)
Patient Problem Meningitis (2389)
Event Date 12/11/2017
Event Type  Injury  
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
Additional information was received from the healthcare professional via manufacturer representative (rep). It was reported that the patient was hospitalized awaiting explantations of the pump and catheter and was being treated for infection. Explant had occurred and the devices were sent to the lab. The rep had requested both pump and catheter be given to him for return. The lab results were: negative for bacterial infection; testing for fungal had not been completed and would take 10-14 days. The cause of fungal meningitis/contamination was undetermined. No further complications were reported.
 
Manufacturer Narrative
The main component of the system and other applicable components are: product id: 8780, serial# (b)(4), implanted: (b)(6) 2017, product type: catheter. If information is provided in the future, a supplemental report will be issued.
 
Event Description
Information was received from a healthcare professional via manufacturer representative (if applicable) regarding a patient who was receiving infumorph (10. 0 mg/ml, 1. 0 mg/day) via intrathecal drug delivery pump for non-malignant pain. It was reported that the catheter and pump were implanted normally on (b)(6) 2017 and an infection (fungal meningitis) and contaminated implant was suspected. Labs were being run and would take 5-7 days. The pump and catheter were planned to be explanted on (b)(6) 2017. The issue was not resolved and the patient status was unknown at the time of this report. It was unknown whether the pump and catheter would be returned to the manufacturer. 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 Key7112980
MDR Text Key103336909
Report Number3004209178-2017-25909
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 12/20/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/13/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date04/28/2019
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 Received12/20/2017
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured11/02/2017
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: 12/13/2017 Patient Sequence Number: 1
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