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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MDT PUERTO RICO OPERATIONS CO SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE

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MDT PUERTO RICO OPERATIONS CO SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE Back to Search Results
Model Number 8637-40
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Apnea (1720); Fall (1848); Fatigue (1849); Bone Fracture(s) (1870); Pain (1994); Injury (2348)
Event Date 07/05/2016
Event Type  Injury  
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.
 
Event Description
Additional information received from a healthcare provider (hcp) via a clinical study indicated the patient's baseline weight was (b)(6) lbs.
 
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
Additional information received from a healthcare provider (hcp) via a clinical study indicated that the outcome of the event was ongoing. No further complications were reported/anticipated.
 
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
Additional information received from a healthcare provider (hcp) via a clinical study reported the event resolved without sequelae on (b)(6) 2018.
 
Manufacturer Narrative
A good faith effort will be made to obtain the applicable information relevant to the report. 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 clinical study regarding a patient receiving fentanyl (2000. 0 mcg/ml at 1280. 7 mcg/day), morphine (2. 4 mg/ml at 1. 5368 mg/day), and bupivacaine (5. 0 mg/ml at 3. 2017 mg/day) via an implantable infusion pump. The indication for use was noted as non-malignant pain and lumbar radiculopathy. It was reported the patient experienced excessive somnolence. Laboratory testing on (b)(6) 2016 with a sleep study gave results of mild sleep apnea. The patient's gabapentin was decreased by 300 mg on (b)(6) 2016. The patient experienced the excessive somnolence on (b)(6) 2016. The pump was reprogrammed on (b)(6) 2016 as an intervention. The event resulted in an urgent care visit. The patient continued to have frequent falls and she sometimes fell asleep while she was on the toilet and had broken several bones and had injured herself. The patient most recently fell during the day while going to the bathroom and was seen for fracture of her toes. The patient had some studies and they did not find any sleep disorder. It was felt that her excessive somnolence was related to her medications. The outcome of the event was noted as resolved without sequelae on (b)(6) 2016. The etiology of the event was noted as possibly related to the device or therapy, not related to the implant procedure, and possibly related to the drug fentanyl with the drug action that caused the event being no change in drug.
 
Event Description
Additional information indicated the etiology was defined as possibly related to fentanyl and there was no change in drug. On (b)(6) 2017 it was reported the patient admitted to a history of sleep apnea and was awoken by pain and not the device.
 
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Brand NameSYNCHROMED II
Type of DevicePUMP, INFUSION, IMPLANTED, PROGRAMMABLE
Manufacturer (Section D)
MDT PUERTO RICO OPERATIONS CO
rd 31 km 24 hm 4
juncos PR 00777
Manufacturer (Section G)
MDT PUERTO RICO OPERATIONS CO
rd 31 km 24 hm 4
juncos PR 00777
Manufacturer Contact
lisa woodward clark
7000 central avenue ne rcw215
minneapolis, MN 55432
7635263920
MDR Report Key6256285
MDR Text Key101736482
Report Number3004209178-2017-00994
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 09/19/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/17/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date03/14/2014
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 Received09/19/2018
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured09/25/2012
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: 01/17/2017 Patient Sequence Number: 1
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