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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 Problems Material Too Rigid or Stiff (1544); Unstable (1667); Improper or Incorrect Procedure or Method (2017); Device Displays Incorrect Message (2591); Device Operates Differently Than Expected (2913); Material Integrity Problem (2978)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 07/01/2017
Event Type  Injury  
Manufacturer Narrative
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. Conclusion code ¿ is being updated regarding the pump and catheter for this event. 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 pump and catheter were sent to the manufacturer to be analyzed. It was reported the reason the doctor wanted it analyzed was that they noted the catheter seemed to be fragile and it seemed like the catheter had hardened over time. No further complications were reported/anticipated or expected.
 
Manufacturer Narrative
The other relevant component includes: product id 8731 (b)(4) implanted: (b)(6)2006 explanted: (b)(6)2017 product type catheter. Evaluation of implantable pump (b)(4) did not reveal any anomalies. The returned pump passed all functional testing in the lab. Evaluation of implantable catheter (b)(4) revealed multiple user related holes in the body of the catheter, and identified a compressed region on the body of the catheter. If information is provided in the future, a supplemental report will be issued.
 
Manufacturer Narrative
The main component of the device system; the other relevant components include: product id: 8731, serial# (b)(4), implanted: (b)(6) 2006, product type: catheter. 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) regarding a patient who was receiving 5000 mcg/ml fentanyl at a dose of 2500 mcg/day via an implantable infusion pump for malignant pain, degenerative disc disease/herniated disc pain, and spinal pain. It was suspected that the patient had a flipped pump. The hcp suspected it was flipped due to refill troubles they have had. It was reported that the hcp may have missed the port and injected the drug subcutaneously when refilling. The patient ended up in intensive care for 3-5 days. No specific symptoms were mentioned. The hcp reported that the pump was empty and they may try to manually flip the pump and fill it with saline until the patient can see the surgeon. It was reported the patient had a ct scan that made the hcp think that the catheter may be cut off or fragmented. It was reported the ct scan was done about two weeks prior to (b)(6) 2017. No further complications were anticipated/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 Key6750178
MDR Text Key100188513
Report Number3004209178-2017-15767
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
Remedial Action Recall
Type of Report Initial,Followup,Followup,Followup
Report Date 10/30/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/28/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date02/28/2014
Device Model Number8637-40
Device Catalogue Number8637-40
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer09/11/2017
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/20/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured09/07/2012
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Removal/Correction NumberZ-1060-2011

Patient Treatment Data
Date Received: 07/28/2017 Patient Sequence Number: 1
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