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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); Obstruction of Flow (2423); Infusion or Flow Problem (2964)
Patient Problem Muscular Rigidity (1968)
Event Date 06/17/2022
Event Type  Injury  
Event Description
Information was received from multiple sources (manufacturer representative, healthcare provider, foreign) regarding a patient who was receiving baclofen (500 mcg/ml at 99 mcg/day) via an implantable pump. It was reported that at the scheduled pump refill on (b)(6) 2022, the physician found 18 ml of baclofen in the pump's reservoir while the expected volume was 1. 8 ml. Regarding diagnostics/troubleshooting performed, it was indicated that reading notes, no abnormal events were reported. At the last refill on (b)(6) 2022, there was no anomaly during refill. The patient presented stiffness. The physician was considering arranging a session to check for possible kinking of the catheter with the contrast medium. Factors that may have led or contributed to the issue were unknown. The issue was not resolved as of (b)(6) 2022. The patient's medical history, gender, age, and weight at the time of the event was unknown or would not be made available. Additional information was received from a foreign healthcare provider via a company representative on 2022-jun-21. On (b)(6) 2022 a rotor test showed no abnormalities. It was further noted that on the other hand, direct access to the catheter revealed a catheter obstruction. A catheter revision was to be carried out in july.
 
Manufacturer Narrative
Concomitant medical products: product id: 8780, lot#: unknown, product type: catheter. Other relevant device(s) are: product id: 8780, serial/lot #: unknown. If information is provided in the future, a supplemental report will be issued.
 
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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
glen belmer
7000 central avenue ne rcw215
minneapolis, MN 55432
6122713209
MDR Report Key14758504
MDR Text Key295034595
Report Number3004209178-2022-07927
Device Sequence Number1
Product Code LKK
Combination Product (y/n)N
Reporter Country CodeIT
PMA/PMN Number
P860004
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional,Company Representative
Reporter Occupation
Type of Report Initial,Followup,Followup,Followup
Report Date 07/18/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/21/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date12/14/2021
Device Model Number8637-20
Device Catalogue Number8637-20
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received07/15/2022
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured06/15/2020
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: 06/21/2022 Patient Sequence Number: 1
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