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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 Filling Problem (1233); Pumping Stopped (1503); Short Fill (1575); Mechanical Jam (2983)
Patient Problems Unspecified Infection (1930); Seroma (2069); No Known Impact Or Consequence To Patient (2692); No Information (3190)
Event Date 06/01/2018
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 healthcare provider via a company representative regarding a patient receiving lioresal concentration not reported, at approx. 700mcg/day via an implantable pump. The indications for use were intractable spasticity and cerebral palsy. It was reported that the healthcare provider at the managing physician¿s office saw the patient for a visit. On (b)(6) 2018 the healthcare provider called the company representative and reported there was a motor stall in the logs and on top of programming. The motor stall had not recovered. Per the reporter it looked like the patient had a motor stall in (b)(6) 2018. It was noted that the patient was followed by the physician for regular refills prior to seeing this physician. Per the healthcare provider, the family had stated the day of the report that they were not able to fill the pump completely. The patient was referred to the surgeon for troubleshooting of the pump. The patient was scheduled for pump replacement on (b)(6) 2018. There were no signs of withdrawal per the healthcare providers report. There were no environmental, external or patient factors that may have led or contributed to the issue. The issue was not resolved at the time of the report and it was noted that the healthcare provider would not have any further information regarding the event. No further complications were reported.
 
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
The patient status was noted as alive, no injury.
 
Manufacturer Narrative
(b)(4). If information is provided in the future, a supplemental report will be issued.
 
Event Description
Additional information was received on (b)(6) 2018 and it was reported that the patient was taken to surgery to replace the pump, but there was an infection in the pocket. The physician was able to get approximately 3 cc of yellowish fluid out of the pump pocket. The pump and a portion of the pump segment of the catheter were explanted. The spinal segment of the catheter was left implanted and was tied off. No further complications were reported/anticipated.
 
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 Key7741800
MDR Text Key115764606
Report Number3004209178-2018-17217
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
Type of Report Initial,Followup,Followup,Followup
Report Date 10/03/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/02/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date04/28/2013
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 Received08/08/2018
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured11/08/2011
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: 08/02/2018 Patient Sequence Number: 1
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