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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 Pumping Stopped (1503); Battery Problem (2885)
Patient Problems Therapeutic Response, Decreased (2271); No Known Impact Or Consequence To Patient (2692)
Event Date 05/05/2018
Event Type  Injury  
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
Information was received from a healthcare provider (hcp) regarding a patient receiving intrathecal gablofen 2000 mcg/ml at 1567. 6 mcg/day via an implanted pump for intractable spasticity and head/brain injury. An alarm was heard and telemetry was not yet performed. The patient was in the emergency room (er) reporting a critical alarm. The reporter wanted to know if this pump was part of the battery performance field action and it was confirmed it was not included in this population. It was recommended to interrogate the pump and possibly contact a manufacturer representative (rep) for assistance. Patient symptoms were not reported. The event date was (b)(6) 2018. No further complications were reported/anticipated or expected. Additional information was received from a healthcare provider (hcp) via a manufacturer representative. It was reported that the pump had a premature motor stall. Elective replacement indicator was in 12 months from (b)(6) 2018. It was reported that the critical alarm started going off on (b)(6) 2018, which conflicted with the previous report. No environmental, external, or patient factors were reported to have caused this issue. When reading the logs, it showed that a motor stall occurred. The pump was replaced with a 40cc pump. The issue was said to have been resolved and the patient was "alive- no injury. " there were no further complications reported at this time.
 
Manufacturer Narrative
Analysis results were not available at the time of this report. A follow-up report will be sent when analysis is completed. The returned pump was interrogated and as per the logs the following medications were being administered via a simple continuous dose rate as of (b)(6) 2018: gablofen with concentration 2,000 mcg/ml at a dose rate of 12. 7 mcg/day. If information is provided in the future, a supplemental report will be issued.
 
Event Description
Additional information was received from a company representative (rep) via the return paperwork for the pump. It was reported the patient was receiving lioresal 2,000 mcg/ml at 1,568. 9 mcg/day. The pump was replaced on (b)(6) 2018. The critical alarm started going off on (b)(6) 2018 and the patient went to the er. The logs showed a motor stall occurred and the pump was replaced. It was noted there was no patient injury and the patient¿s status after the device was removed was ¿recovered without sequela. ¿ it was further reported the battery was depleted and the patient had a sudden loss of therapy. A rotor study and dye study were not performed. No further complications were reported/anticipated or expected.
 
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
Additional information was received from a consumer indicated they had changed the doctor since the pump quit working so they had to replace the old pump. No other information was provided. No further complications were reported/anticipated or expected.
 
Manufacturer Narrative
Analysis revealed pump motor and gear train anomalies related to corrosion and/or wear and/or lubrication, and stall due to shaf t-bearing. (b)(4). If information is provided in the future, a supplemental report will be issued.
 
Manufacturer Narrative
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 woodward clark
7000 central avenue ne rcw215
minneapolis, MN 55432
7635263920
MDR Report Key7500320
MDR Text Key107783985
Report Number3004209178-2018-10496
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,consum
Reporter Occupation Other Health Care Professional
Remedial Action Recall
Type of Report Initial,Followup,Followup,Followup,Followup
Report Date 10/05/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/09/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date10/28/2013
Device Model Number8637-40
Device Catalogue Number8637-40
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer05/25/2018
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/08/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured05/11/2012
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Removal/Correction NumberZ-0497-2013

Patient Treatment Data
Date Received: 05/09/2018 Patient Sequence Number: 1
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