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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 Problem Excess Flow or Over-Infusion (1311)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 03/07/2022
Event Type  malfunction  
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
Information was received from a foreign healthcare provider (hcp) via a manufacturer's representative (rep) regarding a patient with an implantable pump. On (b)(6) 2022, it was reported that an out of specification volume discrepancy was observed during a pump implant procedure on (b)(6) 2022. The hcp emptied the pump expecting 37. 5 ml for a 40 ml pump, but was only able to withdraw 32 ml. The hcp refilled the pump with 32 ml of drug and implanted the pump. The issue was considered resolved at the time of the event. No surgical intervention was planned or had occurred. The patient's status at the time of the report was "unknown".
 
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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 Key13828075
MDR Text Key289452300
Report Number3004209178-2022-03484
Device Sequence Number1
Product Code LKK
Combination Product (y/n)N
Reporter Country CodeFR
PMA/PMN Number
P860004
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional,Company Representative
Reporter Occupation
Type of Report Initial
Report Date 03/18/2022
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received03/19/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number8637-40
Device Catalogue Number8637-40
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received03/15/2022
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured10/22/2021
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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