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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 Insufficient Flow or Under Infusion (2182); Application Program Problem (2880)
Patient Problems Muscular Rigidity (1968); Complaint, Ill-Defined (2331)
Event Date 07/14/2019
Event Type  malfunction  
Manufacturer Narrative
Concomitant medical products: product id: 8835, serial#: (b)(4), product type: programmer, patient. If information is provided in the future, a supplemental report will be issued.
 
Event Description
Hold shaneeka 10/15 information was received from a healthcare provider (hcp) on (b)(6) 2019 regarding a patient receiving baclofen (3000mcg/ml at 383. 1mcg/day at maximum activations) via an implanted infusion pump. The indication for use was intractable spasticity. It was reported that the patient's personal therapy manager (ptm) read that the low reservoir alarm date would be (b)(6) 2019 and the hcp's calculations aligned with that date. The patient came into clinic because their empty pump alarm occurred on (b)(6) 2019. The low reservoir alarm had occurred on (b)(6) 2019. It was noted that the patient was due for a refill and therapy was not intentionally discontinued. No troubleshooting could be performed due to lack of access to the product. Pump logs generated at 11:09 on (b)(6) 2019 indicated a "refill pump before (b)(6) 2019 message with a dose of 388. 4mcg/day programmed, logs generated at 11:40 on (b)(6) 2019 indicated a "refill pump before (b)(6) 2019" message with a dose of 383. 1mcg/day programmed, and logs generated at 12:39 on (b)(6) 2019 indicated a "refill pump before (b)(6) 2019" message with a dose of 383. 1mcg/day programmed. It was noted that the patient experienced increased spasticity and other central nervous system (cns) symptoms. Additional information was received from the hcp on 2019-jul-24 and it was confirmed that the ptm refill date indicated (b)(6) which matched the expected clinician programmer refill date they had previously recorded. This was beyond the actual dates which the hcp had never seen before. The cause of the empty pump was the refill date issue, and they were unable to determine the cause of the refill date issue. It was noted that the hcp had worked with the manufacturer to recalculate the refill date with boluses used and it didn't make sense that the pump was empty. It was noted that it seemed like the patient received more medication than programmed. The serial number of the patient was not available. To resolve the empty pump and refill date issue, the patient was refilled and reprogrammed, and the ptm was decoupled/recoupled and reset. No further complications were reported or anticipated.
 
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
Additional information was received from the healthcare provider who stated that the patient needs a new ptm due to the refill date error. No further complications were reported regarding the event.
 
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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 Key8823593
MDR Text Key162296029
Report Number3004209178-2019-14191
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 health professional
Reporter Occupation
Type of Report Initial,Followup
Report Date 07/26/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received07/24/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date02/28/2016
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 Received07/25/2019
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured09/05/2014
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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