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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 8637-20
Device Problems Material Too Rigid or Stiff (1544); Unexpected Therapeutic Results (1631); Obstruction of Flow (2423); Infusion or Flow Problem (2964); Material Integrity Problem (2978)
Patient Problems Pain (1994); Therapeutic Effects, Unexpected (2099); Therapeutic Response, Decreased (2271)
Event Date 05/08/2018
Event Type  Injury  
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
Additional information was received from a company representative (rep) indicated the patient¿s weight at the time of the event and medical history were unknown. The cause of the event was also unknown and the device was sent in the mail for return. No further complications were reported/anticipated or expected.
 
Manufacturer Narrative
Concomitant medical products: product id: 8596sc, serial#: (b)(4), implanted: (b)(6) 2012, explanted: (b)(6) 2018, product type: catheter. Product id: 8711, serial#: (b)(4), implanted: (b)(6) 2008, explanted: (b)(6) 2018, product type: catheter. Information references the main component of the system. Other relevant device(s) are: product id: 8596sc, serial/lot #: (b)(4), ubd: (b)(6) 2014, udi#: (b)(4); product id: 8711, serial/lot #: (b)(4), ubd: (b)(6) 2010, udi#: (b)(4). 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 company representative (rep) regarding a patient receiving intrathecal fentanyl 2000 mcg/ml at 1861. 1 mcg/day, clonidine 675. 3 mcg/ml at 628. 40 mcg/day, morphine 15 mg/ml at 13. 958 mg/day and bupivacaine 11. 8 mg/ml at 10. 981 mg/day via an implanted pump for non-malignant pain. It was asked and unknown when the event/difficulty occurred and the event occurred during normal use. It was reported the patient had not big reports other than her pain was bad, but she noticed her boluses when she gave them to herself. The patient had a routine pump replacement and the patient felt like the therapy was some what helpful, but still had a lot of pain, which was unknown because she had been dealing with pain for many years. On the date of the pump replacement, the 8596sc was replaced and would be returned as well as the 8711. At replacement on (b)(6) 2018 the hcp was unable to clear the catheter and when the doctor went to remove it, the catheter started to break apart. The old catheter was explanted and a new catheter was implanted. It was noted there was no environmental/external/patient factors that may have led or contributed to the issue. Prior to surgery there were no diagnostics/troubleshooting performed. In surgery, the catheter was brittle and just crumbled. No cerebrospinal fluid (csf) was flowing from it. It was noted the issues was resolved at the time of this report and the patient¿s status was ¿alive-no injury. ¿ other medications the patient was taking at the time of the event were unable to obtain, no available. The patient¿s weight and medical history were unknown, but the rep would follow-up for more information. No further complications were reported/anticipated or expected.
 
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Manufacturer Narrative
The catheter (model 8596sc serial # (b)(4)) was returned and analysis found dried blood, drug, or foreign material occlusion in the catheter body. H3: the catheter (model 8711 serial # (b)(4)) was returned and analysis found dried blood, drug, or foreign material occlusion in the catheter body. The pump was returned and analysis found corrosion and-or wear and-or lubrication, a stall due to shaft-bearing, and overinfusion with an undetermined root cause. Result codes applies to the pump and result code applies to both catheters. Conclusion codes apply to the pump and conclusion code applies to both catheters. If information is provided in the future, a supplemental report will be issued.
 
Manufacturer Narrative
Analysis results were not available at the time of this report. A follow-up report will be sent when analysis is completed. If information is provided in the future, a supplemental report will be issued.
 
Event Description
Additional information received from a healthcare professional (hcp) via a clinical study indicated that more recently the patient experienced suboptimal pain relief and was unable to come into the office for a dye study. It was recommended intraoperative evaluation of the catheter system. On (b)(6) 2018 the operation report noted removal of the occluded intrathecal catheter. Surgical observation on (b)(6) 2018 revealed a catheter occlusion and the catheter was explanted/replaced on that date ((b)(6) 2018). The device disposition was remains in patient. The device diagnosis was catheter occlusion and the clinical diagnosis was suboptimal pain relief. The outcome of the event was noted as ongoing, which conflicts with the previously reported information that the issue resolved. The etiology of the event indicated the relationship of the event to the device or therapy was related and indicated the relationship of the event to the implant procedure was not related. The catheter portion was intrathecal/spinal portion. The event date was (b)(6) 2018. No further complications were reported.
 
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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 Key7728404
MDR Text Key115485332
Report Number3004209178-2018-16867
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 05/02/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/27/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date02/28/2014
Device Model Number8637-20
Device Catalogue Number8637-20
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/31/2018
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received05/02/2019
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured09/08/2012
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: 07/27/2018 Patient Sequence Number: 1
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