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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 Improper or Incorrect Procedure or Method (2017); Insufficient Flow or Under Infusion (2182); Device Displays Incorrect Message (2591); Device Operates Differently Than Expected (2913); Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Abdominal Pain (1685); Memory Loss/Impairment (1958); Pain (1994); Therapeutic Response, Decreased (2271)
Event Date 07/01/2017
Event Type  Injury  
Manufacturer Narrative
Section references the main component of the device system; the other relevant components include: product id 8840 lot# serial# (b)(4) implanted: explanted: product type programmer, physician : patient codes (b)(4) apply to the pump. Patient code (b)(4) applies tot he pump and the programmer/8840. Patient code (b)(4) applies to the programmer/8840. Device code (b)(4) no longer applies to the pump instead device codes (b)(4) applies to the pump. Device codes (b)(4) apply to the 8840/programmer. Eval code-conclusion code 92 applies to the pump and the programmer/8840. If information is provided in the future, a supplemental report will be issued.
 
Event Description
Additional information received from consumer and manufacturer representative reported a critical dual alarm on (b)(6) 2017 and the patient was in extreme pain. The pain was so extreme today ((b)(6) 2017) the patient was forgetting things because of the pain. In (b)(6) 2017 the patient heard a single beep alarm. In (b)(6) 2017 (about 4 days ago) the patient fell and hurt their left shoulder area and down the back and through their chest and ribs. The patient went to the healthcare professional (hcp) and nothing was broken from the fall. It was noted the patient fell on (b)(6) 2017 and grabbed the counter. The patient stated they went to the hcp today ((b)(6) 2017) and was previously told the pump was old and was going to stop due to longevity and sent the patient to the on (b)(6) 2017. The patient is supposed to have surgery to replace the pump on (b)(6) 2017. It was noted that the patient goes for a pre-operative magnetic resonance imaging on 2017 (b)(6) and then a preoperative appointment on 2017 (b)(6). It was noted the patient has been taking oral percocet for over a decade and it is not managing the pain needs like the pump did. The patient was receiving dilaudid (hydromorphone), fentanyl, and baclofen all with unknown doses and concentrations. It was reviewed that end of service and elective replacement indicator would be expected during this timeframe. It was reviewed to talk with hcp about oral medication like baclofen so the patient does not go through withdrawal. It was later reported that the patient was admitted (2017 (b)(6)) due to pain. It was reported the pump was beeping every 20 minutes and confirmed they can hear a 2 toned alarm going off. It was confirmed that the patient was due for a refill, but the hcp was unavailable. It was noted they wanted the pump read so they know what drugs were in the pump. A manufacturer representative (rep) later reported they were called out to interrogate the patient's pump. The rep stated the pump was end of service and requested assistance with turning off the alarms. Screen navigation for turning off pump was reviewed, and rep returned to case to turn off the pump. The rep later reported the date of the end of service was (b)(6) 2017. The serial number of the 8840 involved with the end of service was (b)(4). Actions/interventions included the pump was interrogated, confirmed end of service had occurred, and turned pump to off state to silence alarms. The pump was still planned to be replaced on (b)(6) 2017. The rep noted that the end of service had been resolved and the patient's weight was unknown. No further complications were reported/anticipated.
 
Manufacturer Narrative
Device code (b)(4) applies to the pump and was coded due to the pump reaching elective replacement indicator (eri) and the eri was normal. Device code (b)(4) applies to the pump and was coded due to end of service being missed. If information is provided in the future, a supplemental report will be issued.
 
Event Description
Additional information received from a manufacturer representative on 2017-aug-23 reported the pump logs were sent, and the return of the pump will be up to the healthcare professional (hcp) at the time of replacement. The logs showed elective replacement indicator (eri) occurred on (b)(6) 2017 at 7:12. It was also noted in the logs that a motor stall occurred on 2017-jul-31 at 12:46 and a motor stall recovery was noted on (b)(6) 2017 at 13:22. Logs showed end of service occurred on (b)(6) 2017 at 7:12 and a stopped pump period may exceed tube set on (b)(6) 2017 at 7:13. The logs also showed a schedule to replace the pump by (b)(6) 2017. No further complications were reported/anticipated.
 
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
Additional information received from manufacturer representative (rep) on 2017-aug-29 reported the healthcare professional (hcp) decided not to send the pump back for analysis since it was end of service (eos). The catheter was also replaced and will not be returned for analysis per hcp. No further complications were reported/anticipated.
 
Event Description
Information was received from a healthcare professional regarding a patient receiving fentanyl with an unknown dose and concentration, unknown baclofen with an unknown dose and concentration, and dilaudid (hydromorphone) with an unknown dose and concentration via an implantable pump for non-malignant pain and lumbar radiculopathy. It was reported the patient was having a magnetic resonance imaging (mri) and it was related to manufacturer device or therapy. It was noted that the pump alarm keeps going off so the pump was going to be replaced. The patient not that the pump has not been effective. The pump was working, but not like before. The patient stated that the healthcare professional (hcp) said that the pump needs to be replaced. The hcp did not have information on what alarm was occurring. It was noted that the patient experienced abdominal pain and all areas of the back. It was unknown if the symptoms were related to device or therapy. Event date was noted as (b)(6) 2017 (started 4 weeks ago). No further complications were reported/anticipated.
 
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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 Key6757097
MDR Text Key101779907
Report Number3004209178-2017-15980
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,consum
Reporter Occupation
Type of Report Initial,Followup,Followup,Followup
Report Date 08/30/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/01/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date12/14/2011
Device Model Number8637-20
Device Catalogue Number8637-20
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 Received08/29/2017
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured06/22/2010
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: 08/01/2017 Patient Sequence Number: 1
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