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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 01/10/2019
Event Type  malfunction  
Manufacturer Narrative
Concomitant medical products: product id: 8840, serial# unknown, product type: programmer, physician. 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 baclofen 2000 mcg/ml; 500 mcg via an implantable pump. Indication for use was intractable spasticity and spinal cord injury/spinal cord disease. The date of the event was (b)(6) 2019. It was reported a low reservoir alarm occurred on (b)(6) 2019, and an empty reservoir alarm occurred on (b)(6) 2019. No withdrawal symptoms were reported by the patient. The patient had impaired hearing, which may have contributed to him not hearing the low reservoir alarm which started on 1/10. The pump was refilled. The expected residual volume at time of refill on 1/15 was 0. 0 ml; the actual residual volume equaled 4. 0 ml. The volume discrepancy was documented and will continue to be noted at future refills. The low reservoir alarm date at the last refill on (b)(6) 2018, was (b)(6) 2019, but read as (b)(6) 2019, at the refill on (b)(6) 2019. It was reviewed that the alarm date will read as the current date if there is an active alarm. No diagnostics/troubleshooting were performed. Patient status was alive - no injury. The issue was resolved. Patient weight and medical history were asked but were unknown. 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 Key8260113
MDR Text Key133847736
Report Number3004209178-2019-01271
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 01/23/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received01/18/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date07/28/2015
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 Received01/18/2019
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured01/30/2014
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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