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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 Device Alarm System (1012); Protective Measures Problem (3015); Insufficient Information (3190)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 04/20/2022
Event Type  malfunction  
Manufacturer Narrative
Concomitant medical products: product id: neu_unknown_prog, serial#: unknown, product type: programmer, physician. If information is provided in the future, a supplemental report will be issued.
 
Event Description
On (b)(6) 2022, information was received from an healthcare professional (hcp), regarding a patient receiving morphine (10 mg/ml, 2. 499 mg/day) via an implantable pump for non-malignant pain and chronic low back pain. It was reported that the hcp went to update the pump and the update failed resulting in the pump going into a safe mode. It was reviewed that the caller would need to reprogram the pump. The caller had to disconnect to get the old report. The caller stated they would call back if the issue was not resolved. No symptoms or patient complications reported. The caller called again and reported the patient reported that the pump was alarming again so they went back to the home to interrogate the pump. The caller stated that there was nothing in the interrogation stating the pump was alarming. The pump was still in simple continuous. Drug information was collected. The caller stated that the critical alarm was set to every 10 minutes and they have not heard the pump alarm. The caller stated that the patient had tried using her boluses since the caller had left the patient and there was nothing in the session long report indicating that any boluses had been requested. No printer was available to see ptm technical report. The caller was instructed to decouple, then recouple the ptm. The same caller called back and stated they could not see the boluses on the logs for the patient. Troubleshooting actions were reviewed. It was stated, "no issues with the pump but monitor the patient". Troubleshooting reportedly resolved the reported issue.
 
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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 Key14214796
MDR Text Key290459289
Report Number3004209178-2022-05274
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
Reporter Occupation
Type of Report Initial
Report Date 04/26/2022
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received04/26/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date08/14/2018
Device Model Number8637-40
Device Catalogue Number8637-40
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received04/20/2022
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured02/22/2017
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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