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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 Filling Problem (1233); Migration or Expulsion of Device (1395); Obstruction of Flow (2423); Infusion or Flow Problem (2964); Material Integrity Problem (2978)
Patient Problems Seroma (2069); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
Event Date 03/25/2022
Event Type  Injury  
Manufacturer Narrative
Concomitant products: product id: 8709sc, serial#: (b)(4), implanted:(b)(6) 2013, product type: catheter. Product id: 8709sc, serial#: (b)(4), implanted: (b)(6) 2012, product type: catheter. Other relevant device(s) are: product id: 8709sc, serial/lot #: (b)(4), ubd: 09-feb-2014, udi#: (b)(4); product id: 8709sc, serial/lot #: (b)(4), ubd: 25-sep-2014, 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 lioresal (2000 mcg/ml) via an implanted pump. It was reported that the patient went through withdrawal symptoms which raised concerns that there was something wrong with the pump and the nurse also could not get access for refill which raised concern for a pump flip. The patient was taken to surgery. A catheter revision was attempted but upon opening the pocket, the physician found yellow fluid in the pocket and wanted to send it for labs before progressing with putting a new catheter in. The catheter was checked through the cap (catheter access port) and two other connections, but the catheter didn¿t seem to aspirate back. The catheter was twisted and kinked multiple times. During the procedure, they relieved all the kinks and cut the old catheter and there was still no backflow of csf (cerebrospinal fluid) and it was negative for aspiration. A new pump connector was implanted to hook back up to the pump. The pump logs were checked, and the logs were good. The pump was filled with 40 cc and no prime was done due to the negative aspiration. The new starting dose was started at 150 mcg/day because they had tried to fix the catheter during the procedure. They were going to wait until the labs came back to either go back in and fix the catheter or explant if infected. The issue was not resolved at the time of the report.
 
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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 Key13964130
MDR Text Key288275206
Report Number3004209178-2022-04046
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
Report Date 03/31/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/31/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date12/14/2020
Device Model Number8637-40
Device Catalogue Number8637-40
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received03/25/2022
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured06/27/2019
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: 03/31/2022 Patient Sequence Number: 1
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