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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 Electromagnetic Interference (1194); Premature Elective Replacement Indicator (1483); Insufficient Flow or Under Infusion (2182); Inappropriate or Unexpected Reset (2959); Protective Measures Problem (3015)
Patient Problem Seizures (2063)
Event Date 09/18/2019
Event Type  Injury  
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
On (b)(6) 2019, information was received from an healthcare professional (hcp) via a manufacturer representative (rep) regarding a patient receiving lioresal (2,000 mcg/ml, 262. 6 mcg/day) via an implantable pump for intractable spasticity. Information reported an alarm was heard and confirmed by telemetry indicating a reset occurred. The caller also stated that it looked like the pump may have been empty. There were no symptoms reported at this time and troubleshooting could not be performed due to lack of access to the product. The rep called back on the same date and stated they were at the clinic and the patient was seizing. The rep called back again, and stated they had read the logs and there had been a number of pump updates so the rep did not see the reset of safe state, but confirmed premature early replacement indicator (eri) and minimum rate when the pump had been programmed to lioresal 2000 mcg/ml at 262. 6 mcg/day. The rep stated the expected reservoir volume (erv) was 0 mls, but the actual reservoir volume (arv) was 17 mls on the date of this call. The rep stated that on wednesday, the patient was in a magnetic chair for physical therapy (pt) and "that may have had effects on the pump". The rep did not know the details and or gauss level of the magnetic chair. The rep confirmed the reset and safe state via the long session reports.
 
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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 Key9210580
MDR Text Key163121938
Report Number3004209178-2019-19950
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 company representative,health
Reporter Occupation
Type of Report Initial
Report Date 10/18/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/18/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date11/14/2017
Device Model Number8637-40
Device Catalogue Number8637-40
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 Received09/20/2019
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured05/25/2016
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: 10/18/2019 Patient Sequence Number: 1
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