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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 Device Alarm System (1012); Use of Device Problem (1670); Insufficient Flow or Under Infusion (2182); Insufficient Information (3190)
Patient Problems Dyspnea (1816); Muscular Rigidity (1968); Pain (1994); Vomiting (2144); Complaint, Ill-Defined (2331)
Event Date 01/01/2019
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 consumer regarding a patient receiving an unknown dose and concentration of baclofen via an implantable pump for intractable spasticity.It was reported, per the patient, that the pump "is gone, it's not working no more." the patient stated there was no more medicine in the pump and the doctor told him the pump "needs a new life." the patient was redirected to follow-up with the healthcare provider.The patient also reported they could not breathe and it was harder to breathe with their nose, they had stomach issues, vomiting, and "ribs squeezing." the symptoms had been gradual over the past two weeks, relative to (b)(6) 2019.The patient was taking oral baclofen, two at a time, but they were not working.Regarding the report the pump was no longer working, the event date was provided as about 8 months earlier.The patient no longer had a current managing pump doctor.Physician listings were provided.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 patient via the rep on 2019-oct-23.It was reported that the patient is admitted in hospital at the present time.He stated his pump is dead and needs to be replaced.They were referred to the hcp.The rep will continue to follow up with this patient and physician to coordinate pump replacement.On (b)(6) 2019, the patient was seen at the hospital and his pump was interrogated.It was determined the pump is in eos and he needs pump replacement.The patient is scheduled for a surgical consult on (b)(6) 2019 with the doctor, and will be referred to for pump management.
 
Manufacturer Narrative
(b)(6).If information is provided in the future, a supplemental report will be issued.
 
Event Description
Additional information was received on 22-oct-2019 from the patient who reported that his pump was alarming every 10 minutes.It was a single-toned alarm and not a dual-toned alarm.When asked when he first started hearing the alarm, he stated that the pump started alarming every hour 3 months ago, then switched to every 30 minutes, and then suddenly for the last 2 weeks, it was alarming every 10 minutes.The patient was currently in the hospital because there was no medication in his pump.He had been in the hospital for 2 weeks.Due to having no medication in the pump, his body was experiencing symptoms of spasticity and possibly hurting.It was noted that the patient was extremely difficult to hear/understand throughout the duration of the call.The hospital medical staff was treating his symptoms with shots.The patient was told that his pump was dead, and he could not find a healthcare professional (hcp) to manage care of the pump.He had previously lived in another state.Physician listings were sent to the patient and the field was contacted for additional physician names.No further complications have been reported as a result of this event.
 
Manufacturer Narrative
Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.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
Additional information was received from the rep on (b)(6) 2019.It was reported that the patient was referred to a doctor.The rep stated, ¿i believe he is scheduled for a dye study and then would be scheduled for pump replacement.The office is already closed today since it¿s after 5pm.I can confirm with the doctor¿s scheduler on monday.I will also notify her of insurance issue.¿ there were no further complications reported/anticipated.
 
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Brand Name
SYNCHROMED II
Type of Device
PUMP, INFUSION, IMPLANTED, PROGRAMMABLE
Manufacturer (Section D)
MDT PUERTO RICO OPERATIONS CO
rd 31 km 24 hm 4
juncos PR 00777
MDR Report Key9186466
MDR Text Key170267706
Report Number3004209178-2019-19568
Device Sequence Number1
Product Code LKK
Combination Product (y/n)N
PMA/PMN Number
P860004
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,consum
Type of Report Initial,Followup,Followup,Followup
Report Date 12/19/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/14/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date03/28/2013
Device Model Number8637-40
Device Catalogue Number8637-40
Was Device Available for Evaluation? No
Date Manufacturer Received12/06/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Hospitalization; Required Intervention;
Patient Age45 YR
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