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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 8637-20
Device Problems Volume Accuracy Problem (1675); Insufficient Flow or Under Infusion (2182)
Patient Problem Pain (1994)
Event Type  Injury  
Manufacturer Narrative
Concomitant medical products: product id: 8780, serial# (b)(4), implanted: (b)(6) 2013, product type: catheter. If information is provided in the future, a supplemental report will be issued.
 
Event Description
On (b)(6) 2018, information was received from an healthcare professional (hcp) via a manufacturer representative (rep) regarding a patient receiving compounded baclofen (unknown dose and concentration), dilaudid (unknown dose and concentration) and bupivacaine (unknown dose and concentration) via an implantable pump for an unknown indication for use. On (b)(6) 2018, a volume discrepancy at a refill was identified. The rep indicated the volume discrepancy was 8 mls and the "pump had much more mls than the res vol was reporting". Additional information provided indicated the actual reservoir volume (arv) was 19 mls and the expected reservoir volume (erv) was 8 mls (11 mls discrepancy). The patient complained of increased pain (onset date unknown) at the refill. A dye study was performed on (b)(6) 2018 (also reported as "(b)(6) 2018"). The cause of the volume discrepancy was not determined. The pump and catheter would be replaced, but the exact date had not been determined. The date would be "very soon". The resolution of the patient's pain was requested and the rep responded "not yet". The event was not resolved at the time of this report.
 
Manufacturer Narrative
Concomitant medical products: product id: 8780, serial#: (b)(4), implanted: (b)(6) 2013, explanted: (b)(6) 2018, product type: catheter. If information is provided in the future, a supplemental report will be issued.
 
Event Description
Additional information was received that reported the explant date was (b)(6) 2018. The patient recovered without sequela. The pump contained hydromorphone (10 mg/ml, 2. 200 mg/day) bupivacaine (15. 0 mg/ml, 3. 300 mg/day) and clonidine (150. 0 mcg/ml, 33. 00 mcg/day).
 
Manufacturer Narrative
Analysis of the pump (sn: (b)(4)) found overinfusion due to an undetermined root cause. Analysis of the catheter (sn; (b)(4)) found no significant anomalies. The catheter was returned incomplete in segments. The previously reported conclusion code 92 no longer applies to this event. The conclusion code has been updated to 67. ; the previously reported device code no longer applies to this event. If information is provided in the future, a supplemental report will be issued.
 
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 Key7421549
MDR Text Key105151804
Report Number3004209178-2018-07787
Device Sequence Number1
Product Code LKK
UDI-Device Identifier00643169100831
UDI-Public00643169100831
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 10/04/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/11/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date01/28/2015
Device Model Number8637-20
Device Catalogue Number8637-20
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/04/2018
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? Yes
Date Device Manufactured07/29/2013
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: 04/11/2018 Patient Sequence Number: 1
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