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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 Premature End-of-Life Indicator (1480); Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Pain (1994)
Event Date 04/16/2018
Event Type  Injury  
Manufacturer Narrative
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 manufacturing representative (rep) regarding a patient receiving 10 mg/ml of morphine at 0. 749 mg/day via an implantable pump for non-malignant pain and post lumbar laminectomy syndrome. It was initially reported on 2018-nov-19 that the patient¿s pump had reached the elective replacement indicator (eri). The patient¿s family indicated that the patient did not experience withdrawal symptoms but did experience an increase in back pain. Regarding any environmental/external/patient factors that may have led or contributed to the issue, it was indicated "he" eri had occurred. It was indicated the healthcare provider interrogated the pump on (b)(6) 2018 and noted the pump should be replaced by 2018-jul-15. The event date was provided as (b)(6) 2018. A pump replacement has been scheduled for (b)(6) 2018. Therefore, the issue had not been resolved at the time of the report. The patient¿s status was provided as alive - no injury. Other medications being taken, patient weight, and medical history were not available. Additional information was received from a healthcare provider via a company representative on (b)(4) 2018. It was noted that a pump refill had been performed with no changes. The elective replacement indicator (eri) was described as having been normal and end of service / end of life occurred on (b)(6) 2018. The pump was not replaced prior to eri and it was indicated as having been unknown why replacement had not taken place prior to reaching the replace by date. It was unknown if the pump was to be returned to the manufacturer and further noted as being dependent on hospital protocol. Regarding if the provided information was confirmed with the physician/account, it was noted that this had been provided to the physician replacing the pump. No further complications were reported or anticipated.
 
Manufacturer Narrative
Review of this mdr and/or additional information received shows that there is no information to reasonably suggest that the device in this report may have caused or contributed to a death or serious injury or that the device in this report has malfunctioned. Therefore, this event no longer meets the reporting requirements stipulated in 21 cfr 803. If information is provided in the future, a supplemental report will be issued.
 
Event Description
Additional information was received from the manufacturing representative (rep). The rep clarified that they did not see the pump logs. The pump had been interrogated by the healthcare provider. The rep stated that all of the information they had regarding the dates and events was on the telemetry report they submitted which showed the device had been interrogated on (b)(6) 2018 and showed that the elective replacement indicator (eri) occurred on (b)(6) 2018, with a message to replace the pump by (b)(6) 2018. Therefore, the end of service/end of life date was not known.
 
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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 Key8112378
MDR Text Key128668455
Report Number3004209178-2018-26431
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
Report Date 12/04/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/28/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date12/28/2012
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 Received11/28/2018
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured06/29/2011
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: 11/28/2018 Patient Sequence Number: 1
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