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

Model Number 8637-20

Device Problems Occlusion Within Device (1423); Insufficient Flow or Under Infusion (2182); Aspiration Issue (2883)

Patient Problems Pain (1994); Therapeutic Effects, Unexpected (2099)

Event Date 03/22/2018

Event Type  Injury  

Manufacturer Narrative

Concomitant medical products: product id: 8731sc, serial# (b)(4), implanted: (b)(6) 2007, product type: catheter.Other relevant device(s) are: product id: 8731sc, serial/lot #: (b)(4), (b)(6), (b)(4).If information is provided in the future, a supplemental report will be issued.

Event Description

Information was received from a consumer regarding a patient who was receiving dilaudid at an unknown dose and concentration via intrathecal drug delivery pump.The indication for use was noted as non-malignant pain and failed back syndrome.It was reported that the patient thought there may be something wrong with the catheter because the patient was not getting any pain relief when using the personal therapy manager (ptm).It felt like the same pain before getting the pump.The pain was in the upper and lower back.The patient had a granuloma test "a few months ago" to see if there was blockage and there was nothing.The healthcare provider (hcp) changed the ptm settings, that helped for a little bit.A test was done a few years prior that did not show presence of granuloma and that was when the patient was given a ptm.The event was reported to have begun about two weeks prior to (b)(6) 2018, in (b)(6) 2018.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 a health care provider (hcp) via a device manufacturer representative.It was reported that the patient had a dye study performed on (b)(6) 2018 due to the lack of pain relief and the hcp was unable to withdraw.The hcp decided to titrate the drug down and was planning on performing a catheter revision within the next two months.The surgery had not been scheduled at the time of the report.There were no known environmental, external or patient factors which may have led or contributed to the issue.The issue was not considered resolved.The patient's status at the time of the report was alive - no injury.No further complications were reported.

Manufacturer Narrative

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

Event Description

Additional information was received from a consumer on (b)(6) 2018.It was reported that a dye study confirmed the patient's suspicion that there was a blockage and the catheter was not delivering the necessary pain medicine properly into the intrathecal space of the spine.The patient reported the pain was "beyond awful." the patient was scheduled for a catheter replacement on (b)(6) 2018 but the surgery was cancelled that day due to an air-conditioning malfunction at the surgical center.The patient was requesting new doctor listings.He planned to follow up with a different doctor.No further complications were reported.

Manufacturer Narrative

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

Event Description

Additional information was received from a manufacturer representative.It was reported that the catheter was replaced.There were no further complications reported at this time.

Manufacturer Narrative

Other applicable components are: product id: 8731sc, serial# (b)(4), implanted: (b)(6) 2007, 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 from a manufacturer representative.It was reported that the catheter was removed on (b)(6) 2018.The catheter was not removed entirely.It was disconnected at the pump site and tied off by the physician.The small segment was discarded.There were no further complications reported at this time.

• Brand Name: SYNCHROMED II
• Type of Device: PUMP, 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 Key: 7400714
• MDR Text Key: 104820145
• Report Number: 3004209178-2018-06587
• Device Sequence Number: 1
• Product Code: LKK
• UDI-Device Identifier: 00643169100831
• UDI-Public: 00643169100831
• 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: company representative,consum
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 06/12/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/14/2015
• Device Model Number: 8637-20
• Device Catalogue Number: 8637-20
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 04/03/2018
• Initial Date FDA Received: 04/05/2018
• Supplement Dates Manufacturer Received: 04/25/2018; 05/18/2018; 06/06/2018; 06/12/2018
• Supplement Dates FDA Received: 04/27/2018; 05/21/2018; 06/11/2018; 06/12/2018
• Date Device Manufactured: 01/16/2014
• 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: 45 YR