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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 Premature End-of-Life Indicator (1480); Improper or Incorrect Procedure or Method (2017); Insufficient Flow or Under Infusion (2182)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Type  Injury  
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Manufacturer Narrative
Concomitant medical products: product id: neu_unknown_prog, serial# unknown, product type programmer, physician. A good faith effort will be made to obtain the applicable information relevant to the report. If information is provided in the future, a supplemental report will be issued.
 
Event Description
Information was received from a device manufacturer representative (rep) regarding a patient who was receiving 500 mcg/ml baclofen at an unknown dose via an implantable pump for intractable spasticity and familial spastic paraparesis. It was reported that a critical alarm was occurring. The pump was interrogated on (b)(6) 2017 and it was noted that eri was reached on (b)(6) 2016. It was explained that the pump had reached end of service (eos) and needed to be replaced. No symptoms were reported and the event date was unknown.
 
Event Description
Additional information was received from a device manufacturer representative (rep) and healthcare provider (hcp). The patient was referred to have their pump replaced, no symptoms of withdrawal were reported, and the pump was noted to be 7 years old. The healthcare provider (hcp) had notified the rep of the event and used their own programmer.
 
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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 clark
7000 central avenue ne rcw215
minneapolis, MN 55432
7635263920
MDR Report Key6245730
MDR Text Key100287133
Report Number3004209178-2017-00720
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
Remedial Action Recall
Type of Report Initial,Followup,Followup
Report Date 01/19/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/12/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date02/28/2011
Device Model Number8637-40
Device Catalogue Number8637-40
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 Received01/13/2017
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured09/11/2009
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Removal/Correction NumberZ-3043-2011

Patient Treatment Data
Date Received: 01/12/2017 Patient Sequence Number: 1
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