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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 Occlusion Within Device (1423); Obstruction of Flow (2423); Battery Problem (2885); Device Operates Differently Than Expected (2913); Infusion or Flow Problem (2964)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Type  Injury  
Manufacturer Narrative
Concomitant medical products: product id: 8709, serial#: (b)(4), implanted: (b)(6) 2012, explanted: (b)(6) 2018 product type: catheter. Other relevant device(s) are: product id: 8709, serial/lot #: (b)(4), ubd: 15-aug-2013, udi#: (b)(4). Interrogation of the device indicated that 1,000 mcg/ml baclofen at 158. 9 mcg/day was being delivered. If information is provided in the future, a supplemental report will be issued.
 
Event Description
Information was received from a healthcare professional (hcp) regarding the patient¿s implantable drug infusion device. The drug being delivered was gablofen. The reason for use was not reported. It was reported that there was battery depletion. The catheter was unable to withdraw/aspirate (only partial catheter), there was an occlusion. There was no dye study performed. The patient was not in a clinical study, the device was used with/in the patient for treatment. There was no patient death. The pump and catheter were returned to the manufacturer. There were no symptoms reported. There were no further complications reported/anticipated.
 
Manufacturer Narrative
Analysis of the pump found that there was over infusion with an undetermined root cause. Analysis of the catheter found that the catheter body was broken. (b)(4). 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.
 
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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 Key7624905
MDR Text Key111864132
Report Number3004209178-2018-13968
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 health professional
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 10/03/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/21/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date10/14/2013
Device Model Number8637-40
Device Catalogue Number8637-40
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/20/2018
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
Date Device Manufactured04/24/2012
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: 06/21/2018 Patient Sequence Number: 1
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