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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 Flushing Problem (1252); Migration or Expulsion of Device (1395); Device Dislodged or Dislocated (2923); Infusion or Flow Problem (2964); No Flow (2991)
Patient Problems Therapeutic Effects, Unexpected (2099); Device Embedded In Tissue or Plaque (3165)
Event Type  Injury  
Manufacturer Narrative
Concomitant medical products: product id: 8780, serial# (b)(4), implanted: (b)(6) 2017, product type: catheter. Other relevant device(s) are: product id: 8780, serial/lot #: (b)(4), (b)(6), (b)(4). If information is provided in the future, a supplemental report will be issued.
 
Event Description
Information was received from a consumer via a device manufacturer representative regarding a patient receiving fentanyl (1000 mcg/ml at 75 mcg/day) via an implantable infusion pump. It was reported that beginning at an unknown date the patient was not receiving therapy as it was predicted they would with medicine. The healthcare provider (hcp) performed a fluoroscopy/dye study but could not find the catheter or aspirate. The catheter was revised and replaced with a new 8780 catheter. There were no environmental/external/patient factors that may have led or contributed to the issue. The issue was reported as resolved and the patient was alive with no injury. The location of the catheter was unknown as there was contradicting reports on whether the catheter was explanted or remained in service. No further complications have been reported as a result of this event.
 
Manufacturer Narrative
Continuation of concomitant products: product id: 8780, ,serial# (b)(4), implanted: (b)(6) 2017, product type: catheter. If information is provided in the future, a supplemental report will be issued.
 
Event Description
Additional information was received from a healthcare provider (hcp) via a device manufacturer representative indicated that the catheter remained implanted but was not active. The replacement (b)(4) was provided. No further complications have been reported as a result of this event.
 
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Manufacturer Narrative
Product id 8780 lot# serial# (b)(4), implanted: (b)(6) 2017. Product type catheter. 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 Key7702220
MDR Text Key114419485
Report Number3004209178-2018-16134
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,Followup,Followup
Report Date 10/04/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/19/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date10/14/2018
Device Model Number8637-20
Device Catalogue Number8637-20
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 Received08/08/2018
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured04/19/2017
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: 07/19/2018 Patient Sequence Number: 1
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