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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 Migration or Expulsion of Device (1395); Infusion or Flow Problem (2964); Protective Measures Problem (3015)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 05/15/2019
Event Type  Injury  
Manufacturer Narrative
Concomitant medical products: product id: 8780, serial#: (b)(4), implanted: (b)(6) 2018, explanted: (b)(6) 2019, product type: catheter. Other relevant device(s) are: product id: 8780, serial/lot #: (b)(4), ubd: 29-nov-2019, udi#: (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 regarding a patient who was receiving infumorph with concentration 4 mg at a dose rate of 1. 34499 mg/day as of (b)(6) 2019 via an implantable pump for non-malignant pain. As of (b)(6) 2019 (report/session date) the pump was administering morphine a dose rate of 1. 38673 mg/day. It was reported that the device diagnosis was catheter dislodgement. The physician had elected to perform fluoroscopy on (b)(6) 2019 to locate the catheter; however, after multiple views they were unable to locate / see the catheter. The entire device system was explanted and replaced on ¿(b)(6) 2019¿ (as reported the date (b)(6) 2019 is conflicting with the reported date of fluoroscopy). The event resolved without sequelae as of (b)(6) 2019. The explanted devices were disposed of by the healthcare provider according to their biohazard instructions. Regarding etiology, the relationship of the event to the device or therapy was related. The event was not related to the implant procedure. The patient¿s weight was not measured at baseline. No patient symptom was reported. No further patient complications have been reported as a result of this event.
 
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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 Key10026687
MDR Text Key190336765
Report Number3004209178-2020-08125
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 health professional,study
Reporter Occupation
Type of Report Initial,Followup,Followup,Followup,Followup
Report Date 05/29/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/05/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date06/14/2019
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 Received05/28/2020
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured12/21/2017
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: 05/05/2020 Patient Sequence Number: 1
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