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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 Volume Accuracy Problem (1675); Insufficient Flow or Under Infusion (2182); Device Ingredient or Reagent Problem (2910)
Patient Problems Unspecified Infection (1930); No Known Impact Or Consequence To Patient (2692)
Event Date 04/26/2018
Event Type  Injury  
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
Information was provided by a healthcare provider (hcp) via a manufacturer¿s representative regarding an implantable intrathecal pump intended to deliver saline [1000 ml/ml] at the minimum rate, indicated for intractable spasticity. It was reported that 16cc of fluid were aspirated out of the pump reservoir on (b)(6) 2018 and it appeared yellow and cloudy. Per the caller, 10cc of saline were put in the pump at implant on (b)(6) 2018. It was stated that all the sterile water was aspirated from the reservoir at the time of implant. Per the physician¿s assistant, the patient has a history of infection, but that there were no symptoms of infection. The hcp was sending the fluid to be analyzed. The hcp put drug in to the pump reservoir, but the caller did not know about the type of baclofen with an unknown concentration, along with the pump being left programmed at minimum rate mode. The caller was to confer with the hcp. No further complications were reported.
 
Manufacturer Narrative
(b)(4). If information is provided in the future, a supplemental report will be issued.
 
Event Description
Additional information was received from a healthcare provider on 2018-may-23. It was reported that the cause of the volume discrepancy was unknown, and that there was an unknown device issue. The expected volume was 9. 8 cc. The cause of the yellow/cloudy appearance of the aspirated fluid was not determined. Regarding the results of the fluid analysis, it was reported that no bacteria were grown. The patient had no symptoms related to the yellow/cloudy appearance of the aspirated fluid. It was reported that on (b)(6) 2018, the preservative-free saline (yellow/cloudy) was removed, they flushed the reservoir with saline, then filled with the baclofen prescription without incident. It was reported that the issues were resolved. No further complications were reported or anticipated. Additional information was received from a business partner on 2018-may-24. The patient¿s medical history included spastic diplegic cerebral palsy and infection. The patient¿s concomitant medications included ms contin (morphine sulfate), tramadol (tramadol hydro chloride), baclofen, promethazine (promethazine hydrochloride) and trazodone (trazodone hydrochloride). Reference regulatory report #3007566237-2018-01665 for the manufacturer's report regarding the infection related to the patient's first pump in (b)(6) 2017.
 
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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 Key7537996
MDR Text Key109047246
Report Number3004209178-2018-11667
Device Sequence Number1
Product Code LKK
UDI-Device Identifier00643169530119
UDI-Public00643169530119
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 06/19/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/23/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date08/28/2019
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 Received05/23/2018
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured03/13/2018
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: 05/23/2018 Patient Sequence Number: 1
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