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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 Fall (1848); Fatigue (1849); Pain (1994); Hip Fracture (2349); Cognitive Changes (2551)
Event Date 09/07/2018
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 regarding a patient who was receiving di laudid (8 mg/ml at 3. 7502 mg/day), bupivacaine (6 mg/ml at 2. 8126 mg/day), clonidine (200 mcg/ml at 93. 75 mcg/day), and fentanyl (400 mcg/ml at 187. 51 mcg/day) via intrathecal drug delivery pump. The indication for use was not noted. It was reported that the patient was very drowsy. The pharmacist and nurse at the patient's bedside on (b)(6) 2018 reported that the patient had not been very alert over the past 48 hours. The hcp refilled the patient's pump on (b)(6) 2018 in the hospital. The hcp requested pump infusion be reduced by 20%. The patient was not receiving any additional intravenous (iv) or oral pain medications. The patient's husband reported the patient fell on (b)(6) 2018 and had broken her right hip. The patient had hip replacement surgery over the weekend. The issue was not resolved and the patient was "alive - with injury. " there were no further complications reported at this time. Additional information was received from the manufacturer representative. It was reported that it was unknown if the device/therapy caused, contributed to, or exacerbated the patient's fall and broken right hip. The hcp did not have an additional update on the patient's status as of (b)(6) 2018. There were no further complications reported at this time.
 
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
Additional information was received from the hcp via a manufacturer representative. It was reported that the patient had been discharged from the hospital to an extended care facility (ecf), having increased pain due to pump dose reduction. The patient was recently re-admitted for symptoms of a myocardial infraction (mi). It was not reported that the device had any cause, contribution to, or exacerbation of symptoms of the patient's mi. There were no further complications reported at this time.
 
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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 Key7881292
MDR Text Key120428672
Report Number3004209178-2018-20789
Device Sequence Number1
Product Code LKK
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
P8600004
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 09/21/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/17/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date10/28/2013
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 Manufactured05/09/2012
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: 09/17/2018 Patient Sequence Number: 1
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