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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MDT PUERTO RICO OPERATIONS CO SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE

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MDT PUERTO RICO OPERATIONS CO SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE Back to Search Results
Model Number 8637-40
Device Problems Volume Accuracy Problem (1675); Insufficient Flow or Under Infusion (2182); Output Problem (3005)
Patient Problems Muscular Rigidity (1968); Muscular Rigidity (1968); No Code Available (3191)
Event Date 12/01/2017
Event Type  Injury  
Manufacturer Narrative
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 company representative (rep) regarding a patient receiving intrathecal lioresal 500 mcg/ml at 191. 36 mcg/day via an implanted pump for intractable spasticity. The rep was called to assist in a pump replacement and possible catheter revision. The patient had experienced an increase in spasticity for the last eight months (2017) despite increased dosing. The home infusion nurse had noticed volume discrepancies for the last eight months where the expected volume was less than the actual residual volume aspirated (i. E. Last refill on (b)(6) 2018 was expected residual volume (erv)
=
10ml and the actual residual volume (arv)
=
14. 5 ml. It was noted there had been inconsistent reports on whether a catheter access port dye study had been performed. The pump logs were checked and there were no alarm present. The patient was not experiencing symptoms with withdrawal, but had increased spasticity. The rep was unsure whether the patient had received therapeutic bolus for symptoms. The change in therapy/symptoms was gradual. The rep was in the operating room (or) with the managing physician. It was reported the product would be returned. The rep also inquired if the pump was replaced and the catheter was unremarkable, what dose to start at. It was reviewed this was a medical decision and to consider trialing a single bolus. No further complications were reported/anticipated or expected.
 
Manufacturer Narrative
Analysis of the pump found no anomaly. If information is provided in the future, a supplemental report will be issued.
 
Manufacturer Narrative
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)
MDT PUERTO RICO OPERATIONS CO
rd 31 km 24 hm 4
juncos PR 00777
Manufacturer (Section G)
MDT PUERTO RICO OPERATIONS CO
rd 31 km 24 hm 4
juncos PR 00777
Manufacturer Contact
lisa woodward clark
7000 central avenue ne rcw215
minneapolis, MN 55432
7635263920
MDR Report Key7728795
MDR Text Key115347814
Report Number3004209178-2018-16877
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 10/04/2018
2 Devices were Involved in the Event: 1   2  
2 Patients were Involved in the Event: 1   2  
Date FDA Received07/27/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date05/28/2015
Device Model Number8637-40
Device Catalogue Number8637-40
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer08/07/2018
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/08/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured12/13/2013
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: 07/27/2018 Patient Sequence Number: 0
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