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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 Electromagnetic Interference (1194); Protective Measures Problem (3015)
Patient Problems Muscular Rigidity (1968); Nausea (1970); Therapeutic Response, Decreased (2271); Malaise (2359); No Known Impact Or Consequence To Patient (2692)
Event Date 09/01/2018
Event Type  Injury  
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
Information was received from a health care professional (hcp) regarding a patient receiving gablofen (2000 mcg/ml at 303 mcg/day) via an implantable infusion pump. The indication for use was noted to be intractable spasticity. It was reported that pump interrogation showed a critical alarm occurred on (b)(6) 2018. It was noted safe state was seen in the logs and no other alarms were seen. The caller reported the pump was going to be replaced. The alarm was silenced and the pump was programmed to minimum rate. No patient symptoms were reported. No further complications were reported.
 
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
Additional information was received from an hcp via a clinical study on 2018-sep-28. It was reported that the patient had an episode of nausea and was feeling poorly with increased spasticity. It was noted that tech services was called, and the cause of the pump shifting into safe state was some unknown external electromagnetic interference. It was further noted that the patient was given 25mg of baclofen on 2018-(b)(6). The etiology indicated that the event was related to the device or therapy and was not related tot he implant procedure. The outcome indicated the event was ongoing.
 
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
Additional information received from a healthcare provider reported there were no resets seen in the logs so the hcp reprogrammed the pump and set the dose on 2018-(b)(6). The pump was interrogated on 2018-(b)(6) and was functioning properly with no new events in the logs. The patient's weight was noted as (b)(6) lbs.
 
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
Additional information received from a healthcare provider via a clinical study reported the issue resolved without sequelae on (b)(6) 2018.
 
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
Additional information was received from a health care professional (hcp) on 2018-sep-27. It was reported that the hcp saw a motor stall in (b)(6) 2018 with an immediate recovery due to an mri. He confirmed that the only other event was the safe state on (b)(6) 2018. The hcp was setting the infusion back to simple continuous at 100 mcg/day. He noted the patient did have withdrawal symptoms but didn't realize it and thought she had the flu, so he was going to start her on a lower dose. The hcp confirmed there was no known event that would have triggered the safe state. He was going to give the patient a bolus and have her stay in the office to monitor the pump and see if it returns to safe state. No further complications were reported.
 
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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
lisa woodward clark
7000 central avenue ne rcw215
minneapolis, MN 55432
7635263920
MDR Report Key7907456
MDR Text Key121651559
Report Number3004209178-2018-21497
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,study
Reporter Occupation
Type of Report Initial,Followup,Followup,Followup,Followup
Report Date 10/04/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/25/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date07/14/2016
Device Model Number8637-20
Device Catalogue Number8637-20
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/02/2018
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured01/19/2015
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: 09/25/2018 Patient Sequence Number: 1
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