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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 Pumping Stopped (1503); Infusion or Flow Problem (2964)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 02/19/2022
Event Type  Injury  
Event Description
Information was received from multiple sources (manufacturer representative, healthcare provider) regarding a patient who was receiving morphine (25 mg/ml at 1. 45 mg/day) via an implantable pump for unknown indications for use. It was reported that the healthcare provider (hcp) stated that patient has been hearing pump alarm intermittently. The hcp interrogated pump logs which showed multiple pump motor stalls and recoveries of varying durations starting on (b)(6) 2022. There was no known emi/magnetic source for the stalls. The hcp stated that patient was hospitalized because they went into diabetes ketoacidosis (dka)  and was comatose. The hcp stated that they plan to replace the pump. The issue was not resolved through troubleshooting. Additional information received from the company representative stated both the pump was replaced today. A new 20 ml pump and 8780 catheter were used for implant. Rep stated that patient was found on the ground in their apartment, their blood sugar was 700s (so high they could not read them). The hcp did not feel the pump was the cause of the patient being down, it was related to her blood sugar levels. Pump logs showed a couple more motor stalls since the initial report. Rep stated that the patient did stated they started hearing pump alarm in mid-february. Rep noted that drug, concentration and dose are the same as the previous pump. Patient weight was asked but unknown. The pump was replaced yesterday and will be returned for analysis. The cause of the motor stall was not determined. The issue was resolved.
 
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
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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 Key13749169
MDR Text Key290089316
Report Number3004209178-2022-03177
Device Sequence Number1
Product Code LKK
UDI-Device Identifier00763000422608
UDI-Public00763000422608
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 Non-Healthcare Professional
Type of Report Initial,Followup,Followup
Report Date 06/06/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/12/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number8637-20
Device Catalogue Number8637-20
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Manufacturer Received06/02/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured08/18/2021
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: 03/12/2022 Patient Sequence Number: 1
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