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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 Fluid Leak (1250); Obstruction of Flow (2423); Infusion or Flow Problem (2964); Protective Measures Problem (3015)
Patient Problems Pain (1994); Therapeutic Response, Decreased (2271)
Event Type  Injury  
Manufacturer Narrative
Concomitant medical products: product id: 8780, serial#: (b)(4), implanted: (b)(6) 2016, explanted: (b)(6) 2020, product type: catheter. Other relevant device(s) are: product id: 8780, serial/lot #: (b)(4), ubd: 09-jun-2018, udi#: (b)(4). 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 manufacturer¿s representative (rep) regarding the patient¿s implantable drug infusion device. The drugs being delivered were bupivacaine and dilaudid (hydromorphone) with concentrations of 20 mg/ml at greater than 4 mg/day coming into surgery, after concentration change, dropped to minimum rate of 0. 2401 mg/day. It was reported that the patient had a return of pain. It was unknown when the issue started. There were no known environmental/external/patient factors that may have led or contributed to the issue. Pump check done on (b)(6) 2019. Physicians notes suggest the catheter was occluded and he could not draw back any fluid from the cap. Surgical intervention to find where the occlusion was, and replace that portion of catheter. Done successfully on (b)(6) 2020. The patient experienced no issues. The catheter proved to be patent after the revision. The patient was started at a much lower daily dose and will be titrated up as necessary to achieve pain control. The issue was simple with the pump that seemed to be sucking in air that took up volume in the reservoir, not allowing a full fill with the new concentration of drug. During the surgery, after replacing the proximal segment of the catheter, they reduced the drug concentration from 20mg/ml to 5mg/ml in the pump. While he was trying to push the new drug concentration in to fill the pump, it kept locking up due to air. He would evacuate the air and try to fill again and the same thing would happen. It kept getting air into the pump reservoir, and he deemed that the septum must have a leak and would not put the old pump back in. We opened a new pump, filled it, and implanted. No issues after. There were no known environmental/external/patient factors that may have led or contributed to the issue. The proper needles were used during the evacuation and refill procedure. The doctor is very experienced at this as he manages several hundred pumps and has for many years. The issue was resolved at the time of the report.
 
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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 Key10502149
MDR Text Key212380873
Report Number3004209178-2020-15496
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,Followup
Report Date 11/08/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/08/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date12/28/2017
Device Model Number8637-20
Device Catalogue Number8637-20
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer10/12/2020
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/23/2020
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured07/09/2016
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: 09/08/2020 Patient Sequence Number: 1
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