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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 No Audible Alarm (1019); Premature Elective Replacement Indicator (1483)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 12/19/2016
Event Type  Injury  
Event Description
Information was received from a healthcare provider (hcp) regarding a patient who was receiving 2000 mcg/ml gablofen at a dose of 1100 mcg/day via an implantable pump for intractable spasticity and spinal cord injury/spinal cord disease.It was reported that an alarm was not heard, but confirmed by telemetry.The pump showed an elective replacement indicator (eri) of 13 months in (b)(6) 2016 and showed eri occurred on (b)(6) 2016.The pump logs were checked and no symptoms were reported.Additional information was received on (b)(6) 2017.The patient or others did not hear an alarm.The cause of the premature eri was not determined.The actions and interventions taken were: the hcp consulted with a manufacturer technician, the pump was refilled and no discrepancy was noted in stated and actual reservoir volume, and a referral was made for pump replacement.
 
Manufacturer Narrative
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 clark
7000 central avenue ne rcw215
minneapolis, MN 55432
7635263920
MDR Report Key6300765
MDR Text Key66491346
Report Number3004209178-2017-02515
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 health professional
Reporter Occupation Health Professional
Remedial Action Recall
Type of Report Initial,Followup
Report Date 02/03/2017
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? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 01/12/2017
Initial Date FDA Received02/03/2017
Supplement Dates Manufacturer Received01/12/2017
Supplement Dates FDA Received09/29/2017
Date Device Manufactured02/01/2011
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;
Patient Age66 YR
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