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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 Migration or Expulsion of Device (1395); Positioning Problem (3009)
Patient Problems Erythema (1840); Fall (1848); Swelling (2091); Fluid Discharge (2686)
Event Date 06/11/2018
Event Type  malfunction  
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 regarding a patient who was receiving an unknown drug at unknown dose and concentration via intrathecal drug delivery pump. The indication for use was not noted. It was reported that the pump had flipped. The patient had fallen. The event occurred on (b)(6) 2018. The patient came to the clinic for a refill on (b)(6) 2018 and the hcp discovered it had flipped. He manually flipped it over to fill the pump. The patient called the office on (b)(6) 2018 stating her incision at the pump was red, swollen, and draining. The patient was referred to the surgeon for evaluation. The issue was not resolved and the patient was "alive - no injury. " no surgical intervention occurred; it was unknown if surgical intervention was planned. There were no further complications reported at this time.
 
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 Key7707580
MDR Text Key115087771
Report Number3004209178-2018-16336
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
Report Date 10/04/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received07/20/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date01/14/2019
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 Received08/08/2018
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured07/18/2017
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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