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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 Increase in Pressure (1491); Insufficient Information (3190)
Patient Problem Overdose (1988)
Event Date 10/23/2018
Event Type  Injury  
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
Information was received on 2018-oct-24 from a patient who was receiving dilaudid at an unknown concentration and dose via intrathecal drug delivery pump for spinal pain. It was reported that while the patient was in the hyperbaric chamber, he felt and heard a pop from the pump site when the technician increased the pressure. The pump was more than half full. The patient would follow up with his managing healthcare professional. No further complications were reported. Additional information was received on (b)(6) 2018 from the patient. It was reported that since this issue happened with the hyperbaric chambers, the patient felt the pump pop again when getting it refilled 'today. ' he felt like the housing of the pump was flexing back and forth. He notified his healthcare professional (hcp) who said it was basically not possible. The hcp took pictures over fluoroscopy and did not see any issues. The hcp was able to fill 20ml in the pump successfully. The patient's concern was that the titanium casing cracked and now it would leak, or that it was flexing out now rather than concave and overdosing him. The patient was receiving dilaudid and bupivacaine at 20 mg/ml. The 24 hour dose was 3. 754; 8 boluses of 0. 05 mg; max daily dose 4. 133 mg. No further complications were reported.
 
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
Additional information was received from a healthcare professional (hcp). The hcp reported the patient heard popping from their pump when doing a hyperbaric treatment. The hcp checked the pump after the hyperbaric treatment and the logs were normal and they hcp was able to fill the pump to capacity. The hcp reported that the popping only happened during the hyperbaric treatment. No further complications were anticipated/reported.
 
Manufacturer Narrative
Analysis of the implantable infusion pump (s/n (b)(4)) found no significant anomalies. 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 Key8091595
MDR Text Key127953736
Report Number3004209178-2018-25892
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 Non-Healthcare Professional
Type of Report Initial,Followup,Followup,Followup
Report Date 02/24/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/20/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date12/28/2013
Device Model Number8637-20
Device Catalogue Number8637-20
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/30/2019
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received02/19/2020
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured06/30/2012
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 11/20/2018 Patient Sequence Number: 1
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