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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 8637-20
Device Problem Premature Elective Replacement Indicator (1483)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 04/14/2017
Event Type  Injury  
Manufacturer Narrative
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 healthcare professional (hcp) via a manufacturer's representative (rep) regarding a patient receiving 2,000 mcg/ml lioresal at a dose of 1,038. 7 mcg/day via an implantable infusion pump for intractable spasticity and cerebral palsy. It was reported that a non-critical alarm was heard/confirmed by telemetry. Elective replacement indicator (eri) had occurred and the rep confirmed that premature eri had occurred. Per the implant date of (b)(6) 2011 the eri that occurred on (b)(6) 2017 was premature. The patient was scheduled for pump replacement on (b)(6) 2017. No symptoms were reported, the patient was doing fine clinically and no further complications were expected 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 from a manufacturer's representative (rep) on (b)(6) 2017. It was reported that the date of surgery was mid may not (b)(6) 2017 as previously reported.
 
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 from a healthcare professional (hcp) on 2017-may-08. It was reported that the patient weighed (b)(6) at the time of the event.
 
Event Description
Additional information was received from a healthcare professional (hcp) on 2017-may-30. It was reported that the cause of the pre-mature elective replacement indicator (eri) was presumed to be end of battery life. The pre-mature eri was resolved by the patient undergoing surgery for revision of baclofen pump. The pump was changed on (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 from a manufacturer's representative (rep) on 2017-jun-12. It was reported that the pump was explanted and would not be returned. It was believed that the patient was back to original baseline.
 
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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 Key6521905
MDR Text Key102521477
Report Number3004209178-2017-09066
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,Followup,Followup
Report Date 06/13/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/26/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date11/14/2012
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 Received06/12/2017
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured05/17/2011
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 Treatment Data
Date Received: 04/26/2017 Patient Sequence Number: 1
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