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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 Premature Elective Replacement Indicator (1483)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 07/16/2020
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 healthcare provider (hcp) via a manufacturer representative on 2020-jul-16 regarding a patient receiving lioresal (dose and concentration unknown) via an implanted infusion pump. It was reported that the pump was nearing elective replacement indicator (eri) and a replacement was scheduled. It was noted that looking through prior interrogation records, the last eri date from a (b)(6) 2020 refill was (b)(6) 2022, however, at the time of report the pump stated that eri was in (b)(6) 2020. The hcp was not sure what caused the pump to change the eri, but thought it was worth investigating from a surgical standpoint. The hcp had not read the logs and the flow rate was unknown at the time of report. It was noted that the patient had already been discharged. Pump logs were requested. No patient symptoms were reported and no further complications were reported or anticipated.
 
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
Additional information was received from the device manufacturer representative indicated that the cause for the early replacement indicator was unknown. It was reported that replacement was planned for the middle of august. No further complications have been 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
david gustafson
7000 central avenue ne rcw215
minneapolis, MN 55432
7635149628
MDR Report Key10295007
MDR Text Key199462724
Report Number3004209178-2020-12425
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,Followup,Followup
Report Date 07/23/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/20/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date12/14/2016
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 Received07/21/2020
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured06/16/2015
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: 07/20/2020 Patient Sequence Number: 1
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