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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 Problem Application Program Problem (2880)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 07/15/2020
Event Type  malfunction  
Manufacturer Narrative
Concomitant medical products: product id: 8870, serial#: (b)(4), product type: software. Other relevant device(s) are: product id: 8870, serial/lot #: (b)(4). If information is provided in the future, a supplemental report will be issued.
 
Event Description
Information was received from a healthcare professional (hcp) via a clinical study and a manufacturer representative (rep) regarding a patient receiving remodulin 10 mg/ml for a total dose of 4. 722 mg/day via an implantable pump. It was reported there were unexpected low and empty reservoir alarms in the logs. On (b)(6) 2020, the patient underwent a pump refill and the alarm check was completed post refill. Roughly 10 minutes after this, they heard an alarm go off. The pump was interrogated again, and all looked normal on the interrogation. Per the site, the interrogation post refill included an empty reservoir alarm occurred and a low reservoir alarm occurred both on (b)(6) 2020 at 13:45. The pump status reports were reviewed and found no reason for the critical alarm sounding after the refill on (b)(6) 2020. It was noted that a software bug was suspected as there were 8 similar events. The event will try to be replicated given the programming details. No symptoms were reported. No actions or interventions were taken. The event date was (b)(6) 2020. No further complications were reported/anticipated. (b)(6) 2020 e2 (hcp, sdy, rep): additional information was received from an hcp via a clinical study and manufacturer representative on (b)(6) 2020. It was reported that logs were checked to confirm that the reservoir volume was updated after refill. 40ml were filled into the reservoir and the cause of the issue was believed to be a software bug. The issue was explained and resolved.
 
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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 Key10368091
MDR Text Key201907810
Report Number3004209178-2020-13481
Device Sequence Number1
Product Code LKK
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
P140032
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation
Type of Report Initial,Followup
Report Date 09/08/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received08/05/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date10/14/2019
Device Model Number8637-40
Device Catalogue Number8637-40
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/17/2020
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured04/27/2018
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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