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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC PUERTO RICO OPERATIONS CO. SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE

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MEDTRONIC PUERTO RICO OPERATIONS CO. SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE Back to Search Results
Model Number 8637-20
Device Problems Device Alarm System (1012); Use of Device Problem (1670); Insufficient Flow or Under Infusion (2182)
Patient Problems Muscle Spasm(s) (1966); Muscular Rigidity (1968); Complaint, Ill-Defined (2331); Shaking/Tremors (2515); Sleep Dysfunction (2517)
Event Date 11/15/2019
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 bupivacaine 30mg/ml at 9. 031mg/day, baclofen 3000mcg/ml at 903. 1mcg/day and morphine 30mg/ml at 9. 031mg/day via an implantable pump. The indications for use were intractable spasticity and spinal cord injury/spinal cord disease. On (b)(6) 2019 it was reported that the patient started hearing the non-critical alarm and the patient stated she was pretty sure it started 10days ago. The patient was calling to find a managing healthcare provider for a pump refill as they had missed their scheduled refill. The patient stated they were ¿symptomatic already¿ and very ¿spasmy¿. The patient could not sleep due to the spasming. The patient stated that they were going to seek medical attention and was going to continue working with their former healthcare provider¿s office to get prescription transferred to local office as the patient had recently moved. The patient also stated they were going to the hospital and had contacted their former healthcare provider who was faxing a referral to a new provider. Additional information was received from the patient on (b)(6) 2019 who reported that they were in the hospital because their critical alarm went off yesterday around noon and their pump was empty. Per the patient, the healthcare provider would like to have a representative come out to the hospital to check the pump to make sure the pump was working. The patient did not have a healthcare provider for their pump which was why the pump was empty. No further complications were reported regarding the event.
 
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
Additional information was received on (b)(6)2019 from the patient who reported that she was still in the hospital waiting for her pump to be refilled. Now on (b)(6)2019, she was hearing a new alarm coming from the pump. She stated that the alarm sounded like a ring tone like a phone. It was noted that the sound described was not consistent with a pump alarm. Per the patient, the morphine that was being delivered via the pump was infumorph. No further complications have been reported as a result of this event.
 
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 that reported the patient had increase in spasticity and was shaking so they had went to the hospital. The healthcare provider was the physician at the hospital that works with itb (intrathecal baclofen) pumps and she was looking to potentially fill the pump with just baclofen and wanted to review how to program using the 8840 clinician programmer. The steps were reviewed to program. A bridge bolus was discussed, however the healthcare provider felt uncomfortable programming that since she does not work with pain medication. The healthcare provider would covet the patient with oral medications and leave the pump as is. The patient had an appointment to see the pain healthcare provider in (b)(6) 2020. No further complication were reported or anticipated regarding the event.
 
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Brand NameSYNCHROMED II
Type of DevicePUMP, INFUSION, IMPLANTED, PROGRAMMABLE
Manufacturer (Section D)
MEDTRONIC PUERTO RICO OPERATIONS CO.
road 31, km. 24, hm 4
ceiba norte industrial park
juncos PR 00777
Manufacturer (Section G)
MEDTRONIC PUERTO RICO OPERATIONS CO.
road 31, km. 24, hm 4
ceiba norte industrial park
juncos PR 00777
Manufacturer Contact
lisa woodward clark
7000 central avenue ne rcw215
minneapolis, MN 55432
7635263920
MDR Report Key9395821
MDR Text Key168785624
Report Number3004209178-2019-22857
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 consumer,health professional
Reporter Occupation Non-Healthcare Professional
Type of Report Initial,Followup,Followup
Report Date 12/16/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/02/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date08/28/2016
Device Model Number8637-20
Device Catalogue Number8637-20
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received12/12/2019
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured03/09/2015
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: 12/02/2019 Patient Sequence Number: 1
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