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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 Failure To Service (1563)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 06/25/2018
Event Type  malfunction  
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
Information was received from a consumer and a manufacturer representative on (b)(6) 2018 regarding a patient receiving unknown medi cation (dose and concentration unknown) via an implanted infusion pump. The indications for use included non-malignant pain and failed back surgery syndrome. It was noted that prior to pump implant, about six months after the patient got back surgery in late 2002/early 2003, the patient was on fentanyl patches and ran out of patches. The patient went through complete withdrawal for two days and the healthcare provider (hcp) had to (b)(6) fentanyl overnight. It was reported that the patient was supposed to be filled on monday (relative to the date of report), but was not filled because the doctor was found dead. The patient called around and couldn't find a doctor to fill the pump. Per a manufacturer representative, a new hcp agreed to take the patient, and the patient was calling the office on (b)(6) 2018. No patient symptoms were reported and no further complications were reported or anticipated.
 
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
Additional information was received from the manufacturer representative on (b)(6) 2018. It was indicated the patient had been referred to a new managing physician. However, it was unknown if the missed refill issue had been resolved at the time of the report. The patient's weight was unknown.
 
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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 Key7652902
MDR Text Key112850246
Report Number3004209178-2018-14730
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,consum
Reporter Occupation
Type of Report Initial,Followup
Report Date 07/02/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received06/29/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date12/28/2013
Device Model Number8637-40
Device Catalogue Number8637-40
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/29/2018
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured06/28/2012
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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