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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 Volume Accuracy Problem (1675); Improper Flow or Infusion (2954)
Patient Problem No Known Impact Or Consequence To Patient (2692)
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 foreign healthcare professional (hcp) via a manufacturer representative regarding a patient who was receiving lioresal 1250 mcg/ml at 898. 5 mcg/day and dormicum 1875 mcg/ml at 137. 8 mcg/day via an implantable pump for an unknown indication for use. It was reported that when the refill is done at the due date there is always a discrepancy in the volume the n'vision states and the actual volume left in the pump. It was reported that contrast studies were done twice at different occasions with no catheter issues visible. The specific dates of the contrast studies was not known at the moment. It was reported that the actions taken were to book the refill prior to the actual refill dates were moved forward to prevent the pump being empty to avoid and prevent possible withdrawals. It was reported that the pump was removed 5 months prior to end of service (eos) and dr. (b)(6) asked to assess the pump as nothing is wrong with the catheter according to the physician and the contrast studies. It was reported that the physician and medtronic representative were not aware of any environmental/external/patient factors that may have led or contributed to the issue. It was reported that the pump was explanted and replaced on (b)(6) 2018 and that the patient was in good condition. It was reported that the issue was resolved at the time of this report. The patient status at the time of the report was alive-no injury. No further complications were reported and/or anticipated.
 
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
Additional information was received. It was reported that the date of the event or the first noted volume discrepancy was not known as the doctor programs her patients herself. It was reported that the actual values of the discrepancies for each of the refills was usually between 6-9 ml. It was reported that the actual estimated volumes on the n'vision and the actual volumes aspirated from the pump were not known. The patient's weight at the time of the event was unknown. It was reported that there were no symptoms for the patient. It was reported that the implant date was approximately 7 years ago. No further complications were reported and/or anticipated.
 
Manufacturer Narrative
Additional information was received. It was reported that the correct dose of (b)(6) is 7. 9 mcg/day and the correct dose of (b)(6) is 11. 9 mcg/day. Analysis results were not available as of the date of this report. A follow-up report will be submitted when analysis is complete. Due to imdrf harmonization, any previously submitted device, method, result, and conclusion codes no longer apply to this event. 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
The reported daily dose for lioresal was 898. 5 mcg/day and additional information received reported that the correct daily dose was 899. 5 mcg/day. The reported daily dose for dormicum was 137. 8 mcg/day and additional information received reported that the correct daily dose was 1,349. 3 mcg/day. Patient identifier (b)(6) no longer applies to this event. Analysis of the pump found overinfusion with an undetermined root cause. 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 Key7601676
MDR Text Key111068066
Report Number3004209178-2018-13435
Device Sequence Number1
Product Code LKK
Combination Product (y/n)N
Reporter Country CodeSF
PMA/PMN Number
P860004
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Remedial Action Recall
Type of Report Initial,Followup,Followup,Followup,Followup
Report Date 10/04/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/14/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date03/28/2013
Device Model Number8637-40
Device Catalogue Number8637-40
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/09/2018
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 Manufactured10/04/2011
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Removal/Correction NumberZ-1570-2014

Patient Treatment Data
Date Received: 06/14/2018 Patient Sequence Number: 1
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