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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 Device Alarm System (1012); Premature End-of-Life Indicator (1480); Premature Elective Replacement Indicator (1483); Pumping Stopped (1503); Improper or Incorrect Procedure or Method (2017); Insufficient Flow or Under Infusion (2182); Appropriate Term/Code Not Available (3191)
Patient Problems Therapeutic Effects, Unexpected (2099); No Known Impact Or Consequence To Patient (2692)
Event Date 12/28/2016
Event Type  Injury  
Manufacturer Narrative
Concomitant medical products: product id 8840, product type: programmer, physician.(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
Information was received from a foreign healthcare provider (hcp) via a clinical study regarding a patient who was receiving gablofen (2,000 mcg/ml at 549 mcg/day) via an implantable pump for an unknown indication for use.It was reported that when the hcp went to refill the pump on (b)(6) 2017, they saw the message ¿a terminal event occurs.¿ the event noted was end of service (eos).The hcp also found 15 cc of baclofen in the pump.Surgical intervention did not occur, but was planned.It was not scheduled yet.The product would not be replaced in the future.There were no external factors that may have led or contributed to the issue.No troubleshooting was performed.The product status at the time was implanted ¿ out of service.The issue was not resolved.The patient status was alive ¿ no injury.There were no reported symptoms.No further complications were anticipated.The pump logs were reviewed.The pump was examined on (b)(6) 2016; the elective replacement indicator (eri) was at 21 months.The pump was then examined on (b)(6) 2017.It was discovered that the eri was at 16 months, but the eri had already occurred on (b)(6) 2016.Eos occurred on (b)(6) 2017, with a tube set message appearing two days later.It was also noted that the pump was stopped due to end of service, and the replace by date was noted as (b)(6) 2017.
 
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
Additional information was received.It was reported that the doctor think that no critical alarm occurred at all.No further complications were reported and/or anticipated.
 
Manufacturer Narrative
(b)(4) no longer applies.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
Additional information was received.It was reported that the patient did not experience any symptoms related to the pump reaching end of service (eos).It was reported that there was no critical alarm.It was noted that the doctor know the baclofen was not efficient on this patient.It was noted that there was no explant date for the pump for the moment.
 
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
Additional information was received.It was reported that the pump has been explanted.No further complications were reported and/or anticipated.
 
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
Additional information was received.It was reported that the implant date of the pump was (b)(6) 2011.It was further noted that the pump didn¿t work so treatment was not given to the patient.No further complications were reported and/or anticipated.
 
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Manufacturer Narrative
Analysis of the pump, model# 8637-40, serial#(b)(4), found high battery resistance.Analysis of the unknown catheter found user related holes in the catheter body.If information is provided in the future, a supplemental report will be issued.
 
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Brand Name
SYNCHROMED II
Type of Device
PUMP, 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 Key6404631
MDR Text Key69946398
Report Number3004209178-2017-05594
Device Sequence Number1
Product Code LKK
Combination Product (y/n)N
Reporter Country CodeFR
PMA/PMN Number
P860004
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation Health Professional
Remedial Action Recall
Type of Report Initial,Followup,Followup,Followup,Followup
Report Date 07/27/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date07/28/2012
Device Model Number8637-40
Device Catalogue Number8637-40
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/27/2017
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 03/10/2017
Initial Date FDA Received03/14/2017
Supplement Dates Manufacturer ReceivedNot provided
Not provided
Not provided
Not provided
Not provided
07/25/2017
07/25/2017
Supplement Dates FDA Received03/14/2017
03/28/2017
03/29/2017
06/07/2017
06/12/2017
07/27/2017
10/02/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured02/02/2011
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 Sequence Number1
Patient Outcome(s) Required Intervention;
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