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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 Premature Elective Replacement Indicator (1483); Intermittent Infusion (2341)
Patient Problems Pain (1994); Malaise (2359)
Event Date 01/30/2018
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 via a device manufacturer representative regarding a patient receiving an unknown drug at an unknown concentration and dose via an implantable infusion pump. The indications for use were noted to be non-malignant pain and failed back surgery syndrome. It was reported that the patient stated she had flu-like symptoms and increased pain. Her personal therapy manager (ptm) showed error code 8476, which indicates a motor stall. The patient came into the physician's office on (b)(6) 2018 and her pump was interrogated. The logs showed a motor stall occurring several times. The pump was tentatively scheduled to be replaced "in a couple weeks" with a follow up appointment scheduled for (b)(6) 2018. There were no environmental, external or patient factors which may have led or contributed to the issue. The issue was not considered resolved. 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 hcp via a device manufacturer representative on 2018-mar-23. It was reported that the representative was unable to pump interrogation print outs at the time of the event, and therefore did not know the motor stall specifics. 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) regarding a patient receiving intrathecal fentanyl 2000 mcg/ml at 100 mcg/day and unknown morphine 20 mg/ml at 1 mg/day. The pump was going to be replaced on the date of this report. The reporter was looking at the logs and suspected it may be due to a pre-mature elective replacement indicator (eri). The rep wanted to confirm if the current flow rate would cause the pump to last less than the 7 years. It was reviewed the current flow rate was less than 1 ml/day so that would not be a reason why, unless they had the pump running over 1 ml/day in the past. The rep was also seeing the pump had multiple motor stalls/recoveries. It was unknown if the patient recently had a mri. The patient had a mri back in (b)(6) 2017. The pump status and/or event log report showed a motor stall occurred. Multiple motor stalls <(>&<)> recoveries: (b)(6)2018 10:28- motor stall recovered (logs do not go earlier than this date, could not determine when this stall first occurred), 23:20- motor stall occurred on (b)(6)2018, 24:44- motor stall recovery occurred (b)(6)2018, (b)(6)2018- motor stall occurred (recovered within 4 hrs), (b)(6)2018- motor stall occurred (recovered within 10 mins), (b)(6)2018- motor stall occurred (recovered the next day, lasting 8 hrs), (b)(6)2018- motor stall occurred (recovered within 9 hrs). The motor stalls and recovery time durations were increasing. The rep would ask the patient about electromagnetic interference. Patient symptoms were not reported. It was noted eri occurred on (b)(6)2018 (suspected premature) and it was asked, and unknown when the first motor stall occurred. No further complications were reported/anticipated or expected.
 
Manufacturer Narrative
Analysis of the implantable infusion pump (s/n (b)(4)) found a feed through anomaly of shorting across the insulator. 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 Key7365419
MDR Text Key103297833
Report Number3004209178-2018-05612
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
Remedial Action Recall
Type of Report Initial,Followup,Followup,Followup
Report Date 06/25/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/23/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date03/14/2015
Device Model Number8637-40
Device Catalogue Number8637-40
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer04/17/2018
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/22/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured09/19/2013
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Removal/Correction NumberZ-1579-2013

Patient Treatment Data
Date Received: 03/23/2018 Patient Sequence Number: 1
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