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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 Volume Accuracy Problem (1675); Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Headache (1880); Nausea (1970); Overdose (1988); Vomiting (2144)
Event Date 03/20/2018
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 company representative (rep) regarding a patient receiving intrathecal clonidine 100 mcg/ml at 0. 63 mcg/day, unknown baclofen 10 mcg/ml at 0. 063 mcg/day, and unknown morphine 25 mg/ml at 0. 158 mg/day via an implanted pump for spinal pain. It was reported the patient had been having difficulty for the past couple of weeks with overdosing. The patient was in the hospital with symptoms for a couple of weeks. They aspirated the reservoir and there was almost nothing left in. The patient said they aspirated 1. 7 milliliters (mls), but she had not spoken to the physician for details. The patient¿s symptoms included nausea, vomiting, and headaches. The change in therapy/symptoms was sudden. It was noted the were replacing the pump on the date of this report; however the patient¿s registration said she had an 8709, but the pump interrogation said it was an 8708. Reviewed considerations for an unknown catheter volume if the catheter was an 8709. The event date was 2018, ¿a few weeks ago. ¿ additional information was received, and the pump was replaced and primed on the back table. It was noted they did not see beads on the catheter and it appeared to be an 8709. The catheter was aspirated, and the physician did not want to estimate the catheter volume. Considerations were reviewed for priming an unknown catheter length. Technical services reminded the caller that the volume/cm on the vascular catheter listed was different than the 8709. No further complications were reported/anticipated or expected.
 
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
Additional information was received from the manufacturer's representative on (b)(6) 2018. It was reported that the device was not returned, as it was discarded by the customer.
 
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 Key7425416
MDR Text Key105288464
Report Number3004209178-2018-07881
Device Sequence Number1
Product Code LKK
UDI-Device Identifier00613994779229
UDI-Public00613994779229
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 05/15/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/12/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date01/14/2013
Device Model Number8637-20
Device Catalogue Number8637-20
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received05/14/2018
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured07/21/2011
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Removal/Correction NumberZ-1570-2014

Patient Treatment Data
Date Received: 04/12/2018 Patient Sequence Number: 1
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