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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 8637-40
Device Problems Excess Flow or Over-Infusion (1311); Improper or Incorrect Procedure or Method (2017); Aspiration Issue (2883)
Patient Problems Low Blood Pressure/ Hypotension (1914); Therapeutic Response, Decreased (2271); No Known Impact Or Consequence To Patient (2692)
Event Type  Injury  
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
Additional information was received from the patient's healthcare provider (hcp) via a manufacturer's representative (rep) on (b)(6) 2017. It was reported that the cause of the inability to aspirate the catheter was undetermined. No further complications were reported.
 
Manufacturer Narrative
Concomitant medical products: product id: 8870, product type: software. If information is provided in the future, a supplemental report will be issued.
 
Manufacturer Narrative
Section d refers to the main device, other components include: product id 8840 lot# serial# (b)(4) implanted: explanted: product type programmer, physician product id 8870aau01 lot# serial# (b)(6) implanted: explanted: product type software updated to reflect the information received on 2017-dec-20. Updated to reflect the serial numbers of the physician programmer and software card associated with this event if information is provided in the future, a supplemental report will be issued.
 
Event Description
Additional information was received from the manufacturer's representative (rep) on 2017-dec-20. The rep provided the correct serial number for the programmer involved in the event, as well as the serial number for the aau card. No further complications were reported.
 
Manufacturer Narrative
The main device. Other components include: product id: 8780, serial# (b)(4), implanted: (b)(6) 2017, product type: catheter. Product id: 8840, serial# (b)(4), product type: programmer, physician. 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 manufacturer's representative (rep) regarding a patient who was receiving 2000 mcg/ml of baclofen at 429. 8 mcg/day via an implantable pump for intractable spasticity. On (b)(6) 2017, it was reported that the patient had experienced a decrease in therapeutic effect. The patient experienced some relief initially but not for very long and was now not getting therapeutic relief. It was reported that a dye study was planned and most likely a catheter replacement. According to the rep, this issue was put on the schedule 2 weeks prior to (b)(6) 2017, but they did not hear of the patient issues until (b)(6) 2017. The rep confirmed that they were assigned the case of the dye study on (b)(6) 2017, but did not receive the call for booking the case. The rep stated that they heard of the patient's issues the day of the case when the patient's hcp discussed doing the dye study and catheter replacement. The dye study did not take place because the patient's catheter could not be aspirated. The patient's catheter was replaced when it could not be aspirated. It was later reported that the patient's daily dose was dropped to 96. 1 mcg/day. The rep reported that they programmed a priming bolus for 0. 391 ml rather than the correct catheter volume for the patient of 0. 251 ml. It had been less than 10 minutes since the update at the time of the report, so the drug would not yet be at the catheter tip. The rep later reported that the bolus tab on their programmer was not showing a bolus in progress. Based on the timing, the rep determined that the bolus had been completed. The patient was symptomatic, which was clarified to be that the patient had slightly low blood pressure in the post-anesthesia care unit, after receiving the a 280 mcg bolus of intrathecal baclofen and the patient would be kept overnight to be assessed. The patient's blood pressure was dropping. The rep reported that the patient's blood pressure returned to normal with fluid. The rep noted that the patient typically had low blood pressure and speculated that the issue may be normal for the patient. No other symptoms were noted. The patient's pump was programmed to minimum rate. The patient's issues were considered resolved. No further complications were reported.
 
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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 Key7114269
MDR Text Key103314163
Report Number3004209178-2017-25927
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,Followup,Followup
Report Date 12/21/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/13/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date07/28/2018
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 Received12/20/2017
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured02/02/2017
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: 12/13/2017 Patient Sequence Number: 1
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