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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 Pumping Stopped (1503); Defective Device (2588)
Patient Problems Pain (1994); No Known Impact Or Consequence To Patient (2692)
Event Date 08/03/2018
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 healthcare professional (hcp) via a manufacturer¿s representative (rep) regarding the patient¿s implantable drug infusion device. The drugs being delivered were 6 mg/ml bupivacaine at 3. 7283 mg/day and 25 mg/ml morphine (unknown) at 15. 535 mg/day. The reason for use was non-malignant pain and other chronic/intract pain (truck/limbs). It was reported that a motor stall was seen at initial interrogation. The patient did not recently have an mri. The patient reported hearing the pump alarm on (b)(6) 2018 and then the pump stopped alarming, per the patient. The patient contacted the clinic and they contacted the rep about it on (b)(6) 2018. Event logs confirmed on (b)(6) 2018 at 3:18pm a motor stall occurred with the recovery (b)(6) 2018. The patient stated they did not have mri's, so that was ruled out as the cause of the motor stall. The patient thought they were probably at home watching tv when the stall occurred. Troubleshooting consisted of reviewing pertinent information per the caller's inquires. The rep will confer with the hcp and patient. There were no symptoms reported. There were no further complications reported/anticipated.
 
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
Additional information was received from the rep on 2018-aug-07. It was reported that no cause has been determined. The pump was interrogated in the office yesterday (b)(6) 2018 by rep and logs were obtained. A motor stall was recorded on (b)(6) 2018 and recovered (b)(6) 2018 per the logs. This information was relayed to the nurse. The motor stall has been resolved. The patient¿s weight was not provided. The device is still implanted at this time. The provided information has been confirmed with the patient account. There were no further complications reported/anticipated.
 
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
Additional information received from a consumer indicated that the pump/device was not working. No further complications were reported.
 
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
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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 Key7757212
MDR Text Key116901922
Report Number3004209178-2018-17554
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,Followup,Followup
Report Date 10/04/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received08/07/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date01/28/2014
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 Received08/08/2018
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured08/10/2012
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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