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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 Problems Premature Elective Replacement Indicator (1483); Device Displays Incorrect Message (2591); Inappropriate or Unexpected Reset (2959)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 05/06/2017
Event Type  Injury  
Manufacturer Narrative
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.
 
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 health care provider (hcp) via a manufacturer representative regarding a patient with an implantable drug infusion pump indicated for intractable spasticity and cerebral palsy. The pump contained gablofen [2000 mcg/ml] at a dose of 844. 3 mcg/day. It was reported early replacement indicator (eri) and low reservoir alarm occurred. The representative confirmed the eri alarm was occurring. The low reservoir alarm and eri was not expected. The representative stated at the refill on (b)(6) 2017, the eri was 12 months. The representative stated at the refill today ((b)(6) 2017), the hcp saw the eri occurred on (b)(6) 2017. The representative stated he already reviewed the option of replacing the pump. He stated he would contact the hcp to confirm the pump was in the affected population and discuss replacement options. No patient symptoms were reported. The representative wasn¿t sure of the drug concentration, but thought it was 2000 mcg/ml. The representative stated the patient¿s refill cycle was 42 days. Additional information received from an hcp on (b)(6) 2017 reported the patient was in the office, and the hcp was performing a side port aspiration to verify catheter patency prior to determining if the pump would be replaced. They then programmed a prime bolus to fill the catheter, and during the update, the hcp heard the critical alarm. The hcp interrogated the pump, and a message appeared saying that the pump was in safe state and that low battery reset occurred on (b)(6) 2017. The hcp wanted to know if the prime bolus had completed. The pump update was performed at 11:49 and went into safe state at 11:50. It was then 12:52 at their facility. At 11:49, the hcp programmed the following prime: prime volume of 0. 192 ml and prime duration of 12 minutes. The reservoir volume still read 20 ml. The hcp was discussing trying to replace the pump that day. Additional information receiving from an hcp via a representative on (b)(6) 2017 reported he attended the pump replacement and was preparing to return the pump for analysis. The representative stated he would email in the latest readings. Pump logs provided showed that when examined on (b)(6) 2017 at 15:59, estimated eri was 10 months. Three separate low battery reset and safe state messages occurred on (b)(6) 2017 starting at 11:52. Two motor stall recovery messages also occurred that day between resets, but no motor stall messages occurred. No further patient complications were reported.
 
Manufacturer Narrative
Analysis results were not available as of the date of this report. A follow-up report will be submitted when analysis is complete.
 
Event Description
Additional information was received from a user facility via a manufacturer's representative on 2017-may-10. It was reported that the patient's pump was replaced on (b)(6) 2017. The device was used in the patient and was intended for treatment. There was no patient death related to the event. It was indicated that no patient injury occurred, and the patient recovered without sequela. No further complications were reported/anticipated as a result of the event.
 
Event Description
Additional information received from the hcp reported the patient¿s weight at the time of the event was (b)(6).
 
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 clarification was received regarding the initial report that the elective replacement indicator (eri) and low reservoir alarm (lra) were unexpected. While the reported eri was unexpected, the lra was expected.
 
Manufacturer Narrative
Analysis of the implantable pump serial number (b)(4) confirmed multiple low battery resets and safe state conditions had occurred. However, destructive analysis was unable to determine the cause of the low battery resets. 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 Key6560128
MDR Text Key102903308
Report Number3004209178-2017-10094
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 Notification
Type of Report Initial,Followup,Followup,Followup,Followup
Report Date 06/21/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/11/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date07/28/2012
Device Model Number8637-20
Device Catalogue Number8637-20
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer05/12/2017
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/20/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured02/09/2011
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: 05/11/2017 Patient Sequence Number: 1
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