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

Model Number 8637-20

Device Problems Fluid/Blood Leak (1250); Insufficient Flow or Under Infusion (2182); Adverse Event Without Identified Device or Use Problem (2993); Protective Measures Problem (3015)

Patient Problems Fatigue (1849); Nausea (1970); Overdose (1988); Oversedation (1990); Vomiting (2144); Therapeutic Response, Decreased (2271); No Known Impact Or Consequence To Patient (2692); Constipation (3274)

Event Date 04/17/2019

Event Type  Injury  

Manufacturer Narrative

Concomitant medical products: product id: 8835, serial#: unknown, product type: programmer, patient.Other relevant device(s) are: product id: 8835, serial/lot #: unknown.If information is provided in the future, a supplemental report will be issued.

Event Description

Information was received from a patient who was receiving bupivacaine, 20 mg/ml concentration at 3.003 mg/day, baclofen, 1250 mcg/ml concentration at 187.7 mcg/day and morphine, 2 mg/ml per patient at 300.3 mcg/day dose via intrathecal drug delivery pump for non-malignant pain.It was reported that actual reservoir volume (arv) was less than expected reservoir volume (erv).Patient believed there was something strange with the pump and let the healthcare professional (hcp) know about it.Patient's timelines of events were conflicting.On (b)(6) 2019, the hcp aspirated from the pump reservoir and erv: 6.1 cc when arv: 4cc.In august 2019, arv was 0 cc of clear liquid when the erv was 4cc.Patient never heard any pump alarms when the pump was completely empty per the hcp.The hcp filled the pump and told the patient to watch for anything strange/symptom and he would see the patient in (b)(6) 2019.It was strange that there was no drug left in pump and the patient would not have heard the pump alarming as the low reservoir alarm was programmed at 2 mls.There was a 22 minute programmer/clock/pump variance so that was corrected when the pump was updated.Bolus lock out was reported.Patient activated lock out information per the patient was- intl: 2hrs, max: 6 per day, max: 6 per day and dri: unknown.Patient usually took all the boluses for the patient programmer (ptm) in the allotted 24 hours period.The hcp increased the bupivacaine from 20 to 30 ug, (b)(6) 2019.After that patient went completely numb in both legs for 45 minutes, was stuck on the patio with her dogs and could not walk.Patient had to wait for her husband to get home to help her.On (b)(6) 2019, the extreme nausea (patient was "puking her guts out" for more than a month and it was very different from anything else she had experienced), constipation and sedation began.The hcp refilled the pump and told patient to keep an eye out for anything abnormal.Ever since the pump had been implanted, when patient received a pa bolus, in 10 minute, she felt the effect on the left leg.But now she did not feel anything.Patient reported these issues to the hcp.The hcp knew a lot of other hcps who networked with him but told the patient to find a hcp to do a catheter dye study because the hcp did not want/could not do one due to the liability.The hcp stated maybe the catheter had pitched forward.The hcp did not change out the catheter with the most recent pump implant.Patient took all kinds of biscol/dulcolax and other laxatives and it was not helping her.Patient was receiving too much intrathecal medicine.No further complications were reported.

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

Product id: 8781, serial# (b)(4), implanted: (b)(6) 2013, explanted: (b)(6) 2019, product type: catheter; product id: 8835, serial# unknown, product type: programmer, patient.Section 'device' information references the main component of the system.Other relevant device(s) are: product id: 8780, serial/lot #: (b)(4), ubd: 2014-09-20, udi#: (b)(4).The type of report was changed from previously being a reportable malfunction to now a reportable serious injury regarding additional information received.The previously applied method, results, and conclusion codes remain applicable to both the pump and catheter.If information is provided in the future, a supplemental report will be issued.

Event Description

Additional information was received via a consumer.It was reported that the pump was overdosing the patient.The patient started to have symptoms of drowsiness, vomiting, and constipation.In (b)(6) 2019 the were supposed to pullout 6.2 ml and they pulled out 4.1 ml.In (b)(6) 2019 the patient went to a pump refill were supposed to pull out 4.3 ml, but they pulled out 0.0 ml instead.The pump was described as obviously leaking.The pump was then replaced and they had found that the catheter was leaking.

• Brand Name: SYNCHROMED II
• Type of Device: PUMP, 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 Key: 8972492
• MDR Text Key: 156891966
• Report Number: 3004209178-2019-17172
• Device Sequence Number: 1
• Product Code: LKK
• UDI-Device Identifier: 00643169530119
• UDI-Public: 00643169530119
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P860004
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 01/17/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/06/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/14/2019
• Device Model Number: 8637-20
• Device Catalogue Number: 8637-20
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/08/2020
• Date Device Manufactured: 02/24/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 54 YR