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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 Elective Replacement Indicator (1483); Adverse Event Without Identified Device or Use Problem (2993); Appropriate Term/Code Not Available (3191)
Patient Problems Pain (1994); No Known Impact Or Consequence To Patient (2692)
Event Date 07/10/2018
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 manufacturer representative regarding a patient who was receiving an unknown drug at unknown dose and concentration via intrathecal drug delivery pump. The indication for use was noted as spinal pain. It was reported that the manufacturer representative received an email on (b)(6) 2018 from the clinic that at the appointment on (b)(6) 2018 with the pump refill, the expected reservoir volume (erv) was 10ml and the actual reservoir volume (arv) was 14ml. Also, elective replacement indicator (eri) had occurred on (b)(6) 2018, which was unexpected and the hcp was surprised about that because nothing was done with the pump at the last refill in (b)(6) 2018 and there was 26 months left for the eri at that time. No symptoms were reported. There were no further complications reported at this time.
 
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
Additional information was received from the manufacturer representative. It was reported that the pump was replaced on (b)(6) 2018. There were no further complications reported at this time.
 
Manufacturer Narrative
The main component of the system and other applicable components are: product id: 8780, serial#: (b)(4), implanted: (b)(6) 2013, explanted: (b)(6) 2018, product type: catheter. Analysis results were not available at the time of this report. A follow-up report will be sent when analysis is completed. If information is provided in the future, a supplemental report will be issued.
 
Event Description
Additional information was received from a manufacturer representative. The pump was delivering morphine (25 mg/ml at 17. 389 mg/day) and clonidine (1100 mcg/ml at 765. 1 mcg/day). The infusion pump was returned. The catheter was also returned with no allegations of deficiencies related to the identity, quality, durability, reliability, safety, effectiveness, or performance of the device. There were no further complications reported at this time.
 
Manufacturer Narrative
Analysis of the implantable pump (serial # (b)(4)) identified the start of electromigration across the electrical feed-through insulator along with moisture being present on the insulator. However, an electrical short was not observed during function testing in the laboratory. Analysis identified the pump had reached eri due to voltage, however could not determine the cause. Analysis of the implantable catheter (serial # (b)(4)) identified tearing to the transition tubing. H6 - eval code-method 4118 no longer applies eval code-result 3233 no longer applies. Eval code-conclusion 11 no longer applies. 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.
 
Manufacturer Narrative
(b)(4). 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 Key7694776
MDR Text Key114287588
Report Number3004209178-2018-15935
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,Followup
Report Date 10/30/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/17/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date03/14/2015
Device Model Number8637-40
Device Catalogue Number8637-40
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer08/15/2018
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/30/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured09/18/2013
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: 07/17/2018 Patient Sequence Number: 1
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