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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 8637-20
Device Problems Migration or Expulsion of Device (1395); Communication or Transmission Problem (2896)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 12/06/2019
Event Type  malfunction  
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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 Key15327636
Report Number3004209178-2022-11137
Device Sequence Number1
Product Code LKK
UDI-Device Identifier00643169630505
UDI-Public00643169630505
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 Consumer
Reporter Occupation Non-Healthcare Professional
Type of Report Initial
Report Date 08/31/2022
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received08/31/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date04/28/2021
Device Model Number8637-20
Device Catalogue Number8637-20
Was Device Available for Evaluation? No
Date Manufacturer Received08/24/2022
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured11/11/2019
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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