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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 Infusion or Flow Problem (2964); Material Integrity Problem (2978)
Patient Problems Abdominal Pain (1685); Muscular Rigidity (1968)
Event Date 06/01/2020
Event Type  Injury  
Manufacturer Narrative
Concomitant medical products: product id: 8780, serial#: (b)(4), implanted: (b)(6) 2015, product type: catheter. Other relevant device(s) are: product id: 8780, serial/lot #: (b)(4), ubd: 04-may-2017, 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 via a company representative regarding a patient receiving gablofen 2000mcg/ml at 1 ,100. 5 mcg/day via an implantable pump. On (b)(6) 2020 it was reported that the patient was admitted to the hospital with acute abdominal pain and increased spasticity. The diagnostics and troubleshooting performed was a dye study and a rotor study. The physician could not aspirate the catheter during a catheter dye study and the rotor study showed that the rotors were rotating properly. It was unknown if there were any environmental, external or patient factors that may have led or contributed to the issue. The actions and interventions taken to resolve the issue was a catheter exploration was scheduled for (b)(6) 2020. 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. The patient status was noted as alive, with injury- the patient had abdominal pain. No further complications were reported 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
david gustafson
7000 central avenue ne rcw215
minneapolis, MN 55432
7635149628
MDR Report Key10117885
MDR Text Key194033276
Report Number3004209178-2020-09683
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
Report Date 09/23/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/04/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date09/14/2016
Device Model Number8637-40
Device Catalogue Number8637-40
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/24/2020
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/21/2020
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured03/26/2015
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: 06/04/2020 Patient Sequence Number: 1
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