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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 No Audible Alarm (1019); Pumping Stopped (1503); Application Program Problem (2880); Data Problem (3196)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 01/07/2020
Event Type  malfunction  
Manufacturer Narrative
Concomitant medical products: product id: a810, product type: software. If information is provided in the future, a supplemental report will be issued.
 
Event Description
Information was received from a foreign healthcare professional (hcp) via a manufacturer representative regarding a patient receiving intrathecal clonidine 1,000. 0 mcg/ml at 74. 9 mcg/day via an implantable pump. The indication for use was not reported. It was reported that when the customer interrogated the pump on (b)(6) 2020 at 15:15, the service codes 101 (a pump reset has occurred. Infusion is set to minimum rate. ), 87 (potential loss of therapy : the pump is in safe mode. Therapy is running in minimum rate. ), and 116 ( potential underdose : due to pump memory error, myptm may not accurately access the myptm settings. The issue will be resolved at update. ) appeared on the tablet screen. The customer then closed the session. The patient did not show any withdrawal symptoms at the interrogation. No alarm was reported to go off. After contacting the device manufacturer, the device manufacturer technical services department recommended that they clear the warnings and program the pump according to the therapeutic needs of the patient. The pump was therefore re-interrogated and reprogrammed on (b)(6) 2020 at ¿15:20¿ [logs indicated that the pump was actually re-programmed around 15:32 to 15:33]. The patient was observed for some time, but no sign of underdose or overdose was reported. Logs showed: critical alarm - pump defaulted to minimum rate (07) on (b)(6) 2020 at 15:16 critical alarm - pump reset due to firmware error (2c) on (b)(6) 2020 at 15:16 critical alarm - pump reset (01) on (b)(6) 2020 at 15:16 critical alarm - pump defaulted to minimum rate (07) on (b)(6) 2020 at 15:32 pump motor stall recovery (1a) on (b)(6) 2020 at 15:33. No further complications were reported.
 
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
lisa woodward clark
7000 central avenue ne rcw215
minneapolis, MN 55432
7635263920
MDR Report Key9647827
MDR Text Key176992447
Report Number3004209178-2020-02191
Device Sequence Number1
Product Code LKK
Combination Product (y/n)N
Reporter Country CodeUK
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
Report Date 04/11/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received01/30/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date11/14/2018
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 Received04/11/2020
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured05/15/2017
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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