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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 Difficult to Advance (2920); Material Integrity Problem (2978)
Patient Problem Device Embedded In Tissue or Plaque (3165)
Event Date 02/17/2020
Event Type  Injury  
Manufacturer Narrative
Concomitant medical products: product id: 8731, serial#: (b)(4), implanted: (b)(6) 2006, explanted: (b)(6) 2020, product type: catheter; product id: 8596sc, serial#: (b)(4), product type: catheter; product id: 8578, serial#: (b)(4), product type: catheter; product id: 8596sc, serial#: (b)(4), implanted: (b)(6) 2020, product type: catheter. Other relevant device(s) are: product id: 8731, serial/lot #: (b)(4), ubd: 10-mar-2008, udi#: (b)(4); product id: 8596sc, serial/lot #: (b)(4), ubd: 24-jan-2021, udi#: (b)(4); product id: 8578, serial/lot #: (b)(4), ubd: 27-sep-2020, udi#: (b)(4); product id: 8596sc, serial/lot #: (b)(4), ubd: 20-sep-2020, udi#: (b)(4). If information is provided in the future, a supplemental report will be issued.
 
Event Description
On (b)(6) 2020, information was received from a healthcare professional (hcp) via a manufacturer representative (rep), regarding a patient receiving dilaudid (5 mg/ml, 3. 8018 mg/day) and bupivacaine (8 mg/ml, dose of 6. 0829) for spinal pain. It was reported the hcp went to perform a pump replacement, but upon getting the pump out, he had slight pressure on the catheter and the catheter broke. It was not known if the catheter broke before or during the case. The hcp could see the end of the catheter and wanted to revise just that section. So he opened an 8596sc pump segment revision kit (sn; (b)(4)) and a 8578 (sn; (b)(4)) to see if he could regain access to the intrathecal space. This was not achieved, so the hcp wanted to cut some more of the catheter off and try a little closer to the spine so they opened another 8596sc pump revision segment (sn; (b)(4)). This was also unsuccessful so the hcp opted to clip part of the revision piece (b)(4) and leave a portion of that in the patient along with the old catheter (sn; (b)(4)). The hcp then inserted a new 8780 (sn; (b)(4)) and implanted the new pump (sn; (b)(4)). The issue was resolved at the time of this report. The patient's status was alive - no injury. On (b)(6) 2020, additional information was received from the manufacturer representative (rep). The pump was replaced due to end of service. Catheter ((b)(4)) was discarded. The majority of catheter ((b)(4)) was left in the patient, and the rest was thrown away. The cause of the physician not being able to regain access to the intrathecal space with the replacement catheters was unknown. The reported information has been confirmed with the physician/account.
 
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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
david gustafson
7000 central avenue ne rcw215
minneapolis, MN 55432
7635149628
MDR Report Key9772389
MDR Text Key196389042
Report Number3004209178-2020-04364
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 Notification
Type of Report Initial,Followup,Followup
Report Date 06/01/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/28/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date01/28/2015
Device Model Number8637-40
Device Catalogue Number8637-40
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/09/2020
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received05/29/2020
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured07/29/2013
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Removal/Correction NumberZ-0497-2013

Patient Treatment Data
Date Received: 02/28/2020 Patient Sequence Number: 1
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