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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 Electromagnetic Interference (1194); Pumping Stopped (1503); Protective Measures Problem (3015)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 06/03/2018
Event Type  malfunction  
Manufacturer Narrative
Concomitant medical products: product id: 8709sc, lot# n120274021, implanted: (b)(6) 2007, explanted: (b)(6) 2018, product type: catheter. If information is provided in the future, a supplemental report will be issued.
 
Event Description
Information was received from a healthcare professional via a manufacturer's representative (rep) regarding a patient who was receiving 2000mcg/ml baclofen at 270. 3mcg/day via an implantable infusion pump for an unknown indication for use. It was reported that a motor stall was seen in the interrogation of the pump. A motor stall occurred on (b)(6) 2018 at 08:43 and recovered on (b)(6) 2018 at 09:42. Another motor stall occurred on (b)(6) 2018 at 10:34 during a magnetic resonance imaging scan (mri) and recovery was unknown. A pump replacement was scheduled for (b)(6) 2018. It was reported that the issue was resolved at the time of the report. The patient's status was noted as "alive-no injury. " no further complications were anticipated/reported.
 
Manufacturer Narrative
Product id 8709sc lot# (b)(4) implanted: (b)(6)2007 explanted: (b)(6)2018 product type catheter if information is provided in the future, a supplemental report will be issued.
 
Event Description
Additional information was received from a manufacturer's representative (rep), it was reported that the replacement was done as a normal replacement due to battery life. The reason for the magnetic resonance imaging (mri) scan was unknown. No further complications were anticipated/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 Key7672573
MDR Text Key113501819
Report Number3004209178-2018-15352
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
Report Date 10/05/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/09/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date03/28/2015
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 Received08/08/2018
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured10/02/2013
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Removal/Correction NumberZ-0591-2009

Patient Treatment Data
Date Received: 07/09/2018 Patient Sequence Number: 1
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