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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 Pumping Stopped (1503); Device Displays Incorrect Message (2591); Inappropriate or Unexpected Reset (2959); Protective Measures Problem (3015)
Patient Problems Fall (1848); Therapeutic Response, Decreased (2271); Complaint, Ill-Defined (2331)
Event Date 11/05/2017
Event Type  Injury  
Manufacturer Narrative
(b)(4). 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 an hcp via the representative reported the cause of the alarm on (b)(6) 2017 was unknown. The logs did not show the cause. The code on the patient¿s ptm was unknown. The cause of the pump going into safe state was unknown. The patient went into the office, and the doctor turned the pump on to resolve the patient¿s alarm. The patient was worried the issue could happen again. The hcp said he¿d write oral medicine to help if it occurred again.
 
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
Additional information was received from the healthcare provider (hcp) via the manufacturing representative (rep) on january 29. It was reported the rep was contacted by the managing physician on january 28, 2018 to follow-up with the patient regarding a pump alarm heard by the patient. The patient had indicated their pump was beeping and they felt like they were going into severe withdrawal. It was indicated the patient's elective replacement indicator (eri) would be coming up soon, and the managing physician was "wetting her down from her pump dose" in preparation to have the system explanted. The patient reported they had not had any falls or procedures, nor had they been around any significant areas of "eri" to cause their pump to stall and stop working. It was reported the rep and managing physician planned to interrogate the pump when the patient had their explant to find out the details of the suspected stall. The managing physician had helped the patient with the withdrawal symptoms by subsidizing with oral medications. The order for the explant had been sent to the surgeon, and the healthcare provider was working on getting the patient scheduled for their pump to be explanted. The issue had not yet been resolved. It was indicated the healthcare provider would not have any further information for the manufacturer. Other medications being taken at the time of the event, patient weight, and medical history were unavailable to the manufacturer. The patient's status at the time of the report was provided as "alive-no injury. ".
 
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
Additional information was received from a healthcare professional via company representative. The pump explant was in the process of being scheduled as the patient was being referred to the surgeon for explant. The pump had not been interrogated yet to determine what alarm(s) were occurring. In response to if any further troubleshooting had been performed to determine the cause of the alarm(s) were occurring and withdrawal, it was reported that the physician feels like this was an early low battery stall. No further complications were reported.
 
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
Information was received from a consumer with an implantable drug infusion pump indicated for non-malignant pain, other chronic/intractable pain (trunk/limbs), and chronic low back pain. The pump contained dilaudid with an unknown concentration at a dose of ¿4 mg¿. It was reported the patient had a bad episode on (b)(6) 2017 and tried to give a bolus and got a code on the personal therapy manager (ptm). An ambulance came and got the patient on (b)(6) 2017, and they gave her four shots. The patient said the pump was in safe mode. The patient said she fell on (b)(6) 2017. On (b)(6) 2017, the patient¿s doctor had to turn the pump back on. The patient said now she was hearing a dual tone alarm that probably started last night ((b)(6) 2017). The patient had access to a programmer to do further troubleshooting. The patient tried to look at the alarms to see which alarm was going. The ptm said ¿ok¿; there was no number displayed. There was no out-of-box failure reported. The patient stated she called the health care provider (hcp) and left a message already. No patient symptoms were reported at the time of the call. Additional information received on (b)(6) 2017 from an hcp via a manufacturer representative reported the patient fell on (b)(6) 2017 and then had withdrawal symptoms on (b)(6) 2017. The doctor read the pump, and it stated safe state. The doctor restarted the pump as an action/intervention. The issue was resolved at the time of the report. The patient wanted an explant as they did not want to experience the withdrawal again. Surgical intervention did not occur, and it was unknown if it was planned. The patient¿s weight was unknown. The patient¿s status at the time of the report was alive ¿ no injury. No further patient 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 Key7040826
MDR Text Key100169403
Report Number3004209178-2017-23950
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
Remedial Action Recall
Type of Report Initial,Followup,Followup,Followup,Followup
Report Date 02/15/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/17/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date11/28/2012
Device Model Number8637-20
Device Catalogue Number8637-20
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 Received02/15/2018
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured06/07/2011
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Removal/Correction NumberZ-3043-2011/Z-2276-2009

Patient Treatment Data
Date Received: 11/17/2017 Patient Sequence Number: 1
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