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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 Improper or Incorrect Procedure or Method (2017); Inappropriate or Unexpected Reset (2959); Protective Measures Problem (3015); Appropriate Term/Code Not Available (3191); Data Problem (3196)
Patient Problems Muscular Rigidity (1968); Discomfort (2330); No Clinical Signs, Symptoms or Conditions (4582)
Event Date 12/01/2018
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 foreign healthcare provider (hcp) via a manufacturer's representative regarding a patient who was receiving baclofen (500 mcg/ml at 30 mcg/day) via an implantable pump for an unknown indication for use. It was reported the hcp had worries about a pump. In the middle of (b)(6) 2018, the pump alerted the patient with a critical alarm. It was not time for filling or battery replacement. It was reported the patient had a low dose of 30 mcg/day, 500 mcg/ml. Upon reading, the pump was in safe state and reset had occurred. Aspiration occurred and there was 16 ml left. It was reported the elective replacement indicator (eri) date was 81 months. The patient called again on (b)(6) 2019 and the pump was alarming again. It was additionally stated the patient was at the hospital. There were no reported symptoms. Further complications were not reported. Additional information was received. A session report was provided. The report indicated the pump was in safe state and pump reset had occurred. The report also showed alert 259 (myptm information invalid) and 262 (error accessing myptm settings), indicating a pump memory error had occurred. It was observed the reservoir volume field displayed "- - - - -" at the beginning of the session. It was confirmed the eri displayed 81 months. It was indicated the pump clock was 1405885 hours and 3 minutes behind the programmer clock and was reset to the programmer clock. The dose was updated to 29. 99 mcg/day. The events logs were reviewed. The safe rate in use event occurred on (b)(6) 2019 at 23:12. A reset also occurred at the same timestamp. The pump was updated on (b)(6) 2019 at 14:15 and another safe rate in use event occurred at the same timestamp. Additional information was received. The patient's pump was implanted on (b)(6) 2016. The expected eri date was (b)(6) 2022. It was reported safe state occurred after 2 resets, but logs indicate safe state occurred, then reset, then another safe state. When asked what type of reset occurred, the representative stated, "hard to answer, probable low battery. What happened was that the pump re-setted and the time was out of place so the pump believed it was to old". The patient was not exposed to an mri or any emi prior to the safe state/reset occurring. It was reported when the first reset occurred, it was after an incident when the patient had fallen on the floor. It was stated the cause of the march alarm (safe state/reset) was not determined; it was the same circumstances as the prior reset. The prior pump settings were restored, and during the update the time was adjusted to the correct time. It was stated the issue was resolved when the patient was at a visit, but later that day the issue came back. The patient did not experience any symptoms. Additional information was received. Session logs from (b)(6) 2019 were provided. It was indicated there were no logs to retrieve from (b)(6) 2019. It was stated the patient heard the alarm once an hour. The alarm time for a critical alarm was changed from 1 hour to 10 minutes. It was stated this was bothering the patient very much. A session report from (b)(6) 2019 was provided, indicating the alarm settings were updated. The critical alarm interval was observed to be 10 minutes.
 
Manufacturer Narrative
Product id a810, product type: software. Product id a810, product type: software. 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
david gustafson
7000 central avenue ne rcw215
minneapolis, MN 55432
7635149628
MDR Report Key8475503
MDR Text Key140683606
Report Number3004209178-2019-06554
Device Sequence Number1
Product Code LKK
Combination Product (y/n)N
Reporter Country CodeSW
PMA/PMN Number
P860004
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial,Followup,Followup,Followup,Followup
Report Date 06/17/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/02/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date03/14/2017
Device Model Number8637-20
Device Catalogue Number8637-20
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/23/2021
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/17/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured09/16/2015
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: 04/02/2019 Patient Sequence Number: 1
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