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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); Pumping Stopped (1503)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 08/30/2018
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 consumer and a healthcare provider (hcp) regarding a patient who was receiving dilaudid (25mg/ml at 9. 225mg/day), marcaine (0. 33mg/ml at 0. 9mg/day), and clonidine (250mcg/ml at 92. 25mcg/day) via intrathecal drug delivery pump. The indication for use was noted as non-malignant pain. It was reported that the patient had a refill on (b)(6) 2018, and was told the pump would need to be replaced in 20 months. The pump was refilled on (b)(6) 2018, and he was told there was 3 months before the pump needed to be replaced. No symptoms were reported. The hcp confirmed after looking back at the last three refill session reports, that no anomalies and no alarms other than the (b)(6) 2018, elective replacement indicator (eri) alarm went off. The doses and concentration did not change. There were no further complications reported at this time.
 
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
Additional information received from a manufacturer representative indicated the pump had a premature elective replacement indicator (eri). The manufacturer representative reported review of the logs showed multiple motor stalls and recoveries starting on 2018-(b)(6) and 2018-(b)(6). There was no recovery recorded for the most recent motor stall. The health care provider (hcp) was concerned and had the patient come in on 2018-(b)(6). The patient left before the hcp realized the motor stall did not recover. The manufacturer representative would call the hcp and have them get in contact with the patient. No further information was provided.
 
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
Additional information received from a manufacturer representative indicated the patient was referred to a surgeon for replacement. No surgery had been scheduled. The pump would be returned when replaced. It was noted the surgeon did not return from vacation until the week of (b)(6) 2018. The surgery may be in 2018. No further information was available at this time.
 
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
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. If information is provided in the future, a supplemental report will be issued.
 
Event Description
Additional information received from a manufacturer representative indicated the pump replacement occurred on (b)(6) 2018. The health care provider (hcp) also wanted the catheter to be replaced. The procedure went well. The issue was considered resolved. The patient status was indicated to be alive with no injury. No further complications were reported/anticipated.
 
Manufacturer Narrative
Analysis of the implantable pump (serial # (b)(4)) identified electrochemical migration across the electrical feed-through insulator. Eval codes-method/result/conclusion no longer apply. 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 Key7860066
MDR Text Key120293568
Report Number3004209178-2018-20210
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,Followup
Report Date 04/23/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/10/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date12/14/2014
Device Model Number8637-20
Device Catalogue Number8637-20
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/15/2019
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received04/22/2019
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured06/24/2013
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: 09/10/2018 Patient Sequence Number: 1
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