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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 Pumping Stopped (1503); Intermittent Infusion (2341)
Patient Problems Dysphagia/ Odynophagia (1815); Dyspnea (1816); Muscular Rigidity (1968); Respiratory Distress (2045); Therapeutic Response, Decreased (2271); Irritability (2421)
Event Date 05/24/2018
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 professional (hcp) via manufacturer representative (rep) regarding a patient who was receiving gablofen, 2000 mcg/ml concentration at 593. 3 mcg/day dose via intrathecal drug delivery pump for unknown indication of use. It was reported that motor stall occurred (b)(6) 2018 at 1519; motor stall recovery occurred (b)(6) 2018 at 2006. On (b)(6) 2018, mother called in concerning that the patient was going through acute baclofen withdrawal with respiratory distress. Patient was seen in an emergency room in idaho, then transported to hospital by life flight. At the hospital, he was started on oral baclofen ativan prn, and placed on bi-pap for respiratory support. No environmental/external/patient factors that may have led or contributed to the issue were reported. No diagnostics/troubleshooting was reported. Pump replacement was done on (b)(6) 2018. At the time of this report, the issue was resolved and patient status was alive-no injury. The rep spoke with mom, she stated the patient initially increased irritability, then heard critical alarm on pump. He progressed to "tight muscles" which led to difficulty breathing and difficulty in swallowing. Mom stated the withdrawal symptoms dissipated after motor stall recovery occurred. No further complications were reported. Additional information was received from a healthcare professional (hcp) via manufacturer representative (rep). It was reported that the hcp initially reported this event to give the rep a heads up of pending surgery scheduled for (b)(6) 2018. The explanted pump had been placed in the mail. Tracking number was usps # (b)(4). 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 company representative (rep) via the return paperwork indicated that stopped pump period may exceed tube set on (b)(6) 2018. No further complications were reported.
 
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 Key7557172
MDR Text Key109665254
Report Number3004209178-2018-12232
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
Remedial Action Notification
Type of Report Initial,Followup,Followup,Followup
Report Date 10/04/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/31/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date05/28/2013
Device Model Number8637-20
Device Catalogue Number8637-20
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/05/2018
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 Manufactured12/02/2011
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Removal/Correction NumberZ-0497-2013

Patient Treatment Data
Date Received: 05/31/2018 Patient Sequence Number: 1
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