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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 Problem Device Operates Differently Than Expected (2913)
Patient Problems Fall (1848); Itching Sensation (1943)
Event Date 04/25/2016
Event Type  Injury  
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Manufacturer Narrative
Corrected information: no eval explain code. If information is provided in the future, a supplemental report will be issued.
 
Manufacturer Narrative
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 consumer regarding a patient receiving baclofen via an implanted pump. The indication for pump use was intractable spasticity and spinal cord injury/spinal cord disease. On (b)(6) 2017 it was reported that the patient fell before the pump was replaced. The hcp (healthcare professional) thought the fall could have occurred due to changes in the baclofen dosage prior to the pump replacement. The patient also had itchiness that started about 6 months prior to the pump replacement. The patient was on oral baclofen right before the pump was replaced. The hcp thought the itchiness was due to not getting consistent therapy with the pump and the patient was on oral baclofen. Diagnostic imaging was performed and no issues were determined. The patient was told that the pump was replaced because it was nearing eos (end of service) and it was ¿mechanically inconsistent¿. This had been determined a few months prior to the replacement.
 
Manufacturer Narrative
Analysis results were not available at the time of this report. A follow-up report will be sent when analysis is completed. (b)(4). 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
The pump was returned to the manufacturer via a healthcare provider. The pain pump was described as having reached end of life.
 
Manufacturer Narrative
Analysis of the pump found no significant anomalies; the pump logs indicated that end of service (eos) occurred due to time progression. Interrogation of the pump determined it was used to infuse lioresal [2000. 0 mcg/ml] at 236. 9 mcg/day. (b)(4). 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.
 
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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 Key6335342
MDR Text Key101774364
Report Number3004209178-2017-03971
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 consumer,health professional
Reporter Occupation
Type of Report Initial,Followup,Followup,Followup,Followup
Report Date 04/18/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/16/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date04/28/2011
Device Model Number8637-40
Device Catalogue Number8637-40
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/03/2017
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received04/05/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured11/06/2009
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: 02/16/2017 Patient Sequence Number: 1
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