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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC PUERTO RICO OPERATIONS CO. SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE

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MEDTRONIC PUERTO RICO OPERATIONS CO. SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE Back to Search Results
Model Number 8637-40
Device Problems Migration or Expulsion of Device (1395); Material Integrity Problem (2978); Insufficient Information (3190)
Patient Problem Seroma (2069)
Event Type  Injury  
Manufacturer Narrative
Concomitant medical products: product id: 8731sc, serial#: (b)(4), implanted: (b)(6) 2007, explanted: (b)(6) 2022, product type: catheter; product id: 8598a, serial#: (b)(4), implanted: (b)(6) 2009 , explanted: (b)(6) 2022 product type: catheter ; other relevant device(s) are: product id: 8731sc, serial/lot #: (b)(4), ubd: 05-jun-2009, udi#: (b)(4); product id: 8598a, serial/lot #: (b)(4), ubd: 17-sep-2009, udi#: (b)(4). If information is provided in the future, a supplemental report will be issued.
 
Event Description
Information was received from a healthcare provider (hcp) via a company representative regarding a patient receiving prialt/ziconotide via an implanted pump. It was reported that the pump pocket was filling with fluid that required draining every few days. The hcp believed the seroma may be related to the catheter. It was unknown if there were any environmental, external, or patient factors that may have led or contributed to the issue. The hcp performed a dye study on (b)(6) 2022 and the dye study was inconclusive. A catheter replacement was planned for (b)(6) 2022. The issue was not resolved at the time of the report, and it was indicated that the hcp had no further information to provide regarding the event.
 
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Brand NameSYNCHROMED II
Type of DevicePUMP, INFUSION, IMPLANTED, PROGRAMMABLE
Manufacturer (Section D)
MEDTRONIC PUERTO RICO OPERATIONS CO.
road 31, km. 24, hm 4
ceiba norte industrial park
juncos PR 00777
Manufacturer (Section G)
MEDTRONIC PUERTO RICO OPERATIONS CO.
road 31, km. 24, hm 4
ceiba norte industrial park
juncos PR 00777
Manufacturer Contact
glen belmer
7000 central avenue ne rcw215
minneapolis, MN 55432
6122713209
MDR Report Key13928179
MDR Text Key288026583
Report Number3004209178-2022-03828
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,Company Representative
Reporter Occupation
Type of Report Initial,Followup,Followup,Followup
Report Date 06/24/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/28/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date03/14/2022
Device Model Number8637-40
Device Catalogue Number8637-40
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received06/22/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured09/24/2020
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: 03/28/2022 Patient Sequence Number: 1
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