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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 Difficult to Advance (2920); Material Integrity Problem (2978)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 12/27/2018
Event Type  malfunction  
Manufacturer Narrative
Other relevant device(s) are: product id: 8780, lot/serial#: (b)(4), product type: catheter; ubd: 30-jan-2020, udi#: (b)(4). If information is provided in the future, a supplemental report will be issued.
 
Event Description
Information was received from a healthcare provider (hcp) via a manufacturing representative (rep) regarding a patient receiving an unknown medication via an implantable pump. The indication for use was not provided. The patient¿s information was not provided. It was reported during the implant procedure on (b)(6) 2018, the catheter "got caught around some existing plates and screws and bent. " it was reported the patient had severe scoliosis and had quite a big construct. A different 8780 catheter was implanted instead, and the original catheter was discarded. Therefore, the damaged catheter would not be returned. No symptoms were reported. No further complications were reported or anticipated. Additional information was received from the manufacturing representative (rep). The patient's information was provided, and the indication for use was provided as intractable spasticity. The patient's weight was unknown. Regarding the report that the catheter "got caught around some existing plates and screws and bent," no further descriptive information was available. It was indicated this happened when the catheter was being placed during the implant procedure. The reported information was confirmed with the physician/account.
 
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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 Key8213344
MDR Text Key132266430
Report Number3004209178-2019-00189
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
Report Date 01/03/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received01/03/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date11/28/2019
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 Received12/27/2018
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured06/05/2018
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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