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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 No Audible Alarm (1019); Intermittent Infusion (2341); Device Operates Differently Than Expected (2913)
Patient Problems Abdominal Pain (1685); Diarrhea (1811); High Blood Pressure/ Hypertension (1908); Nausea (1970); Tachycardia (2095); Vomiting (2144); Therapeutic Response, Decreased (2271); Sweating (2444)
Event Date 02/27/2017
Event Type  Injury  
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
Information was received from healthcare provider regarding a patient receiving fentanyl, 6000mcg. /ml at 2881. 5mcg/day, bupivacaine 20mg/ml at 9. 6mg/day and clonidine 1500mcg/ml at 720. 4mcg/day via an implantable pump. The indications for use were non-malignant pain and chronic low back pain. The healthcare provider reported the patient was having withdrawal. The patient was experiencing diaphoresis, tachycardia, diarrhea, nausea, vomiting and abdominal pain. The patient was hospitalized. The healthcare provider was requesting a company representative to come and check the pump. Per the healthcare provider no alarms had been heard at this point. Additional information was received on (b)(6) 2017 from a company representative who reported they saw the patient and interrogated the pump. The logs showed a motor stall occurred (b)(6) 2017 @0715 and motor stall recovery (b)(6) 2017 @1732. The reporter denied any emi or magnetic interaction i. E. Mri. The reporter also stated the patient did not hear the audible alarm.
 
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 information was received from a healthcare provider (hcp) on (b)(6) 2017. It was stated that an alarm was heard, but telemetry had not yet been performed. It was stated that the pump stopped working on (b)(6) 2017. The patient was in withdrawal and admitted to the emergency room (er). Additional information was received on (b)(6) 2017. The hcp requested to program the pump back to the original settings as on (b)(6) 2017 the representative programmed the pump to minimum rate mode because the patient was on intravenous (iv) fentanyl. They wanted the original pump setting programmed, so the patient could be taken off the iv fentanyl.
 
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 information was received on 26-apr-2017 from a healthcare professional (hcp) and it was reported that they did not know why the patient did not hear the pump alarm.
 
Event Description
Additional information was received on 26-apr-2017 from a healthcare professional (hcp) and it was reported that the patient was initially in a hospital that the pump managing physician did not have access to. The pump was interrogated (b)(6) 2017 and found to be in a motor stall. The pump was set to minimum rate and the patient was admitted to the hospital. The patient had withdrawal symptoms, including hypertension. On (b)(6) 2017, the hospital wanted to see if the pump could be increased while the patient was in the hospital, but it couldn¿t be because the pump was in a motor stall. The patient was later transferred to a hospital in the city where the pump managing physician practiced and had hospital access. The patient's pump was replaced on (b)(6) 2017. The patient had a post-operative appointment on (b)(6) 2017. The patient was overall healing up well and the pain was back as baseline.
 
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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 Key6368136
MDR Text Key100706526
Report Number3004209178-2017-04809
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 Recall
Type of Report Initial,Followup,Followup,Followup,Followup
Report Date 04/28/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/01/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date10/14/2013
Device Model Number8637-20
Device Catalogue Number8637-20
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received04/26/2017
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured04/27/2012
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: 03/01/2017 Patient Sequence Number: 1
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