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

Model Number 8637-20

Device Problems Obstruction of Flow (2423); Device Ingredient or Reagent Problem (2910); Infusion or Flow Problem (2964); Material Integrity Problem (2978)

Patient Problems Bradycardia (1751); Fever (1858); Low Blood Pressure/ Hypotension (1914); Muscular Rigidity (1968); Pain (1994); Tachycardia (2095); Therapeutic Response, Decreased (2271)

Event Date 11/29/2018

Event Type  Injury  

Manufacturer Narrative

Other applicable components are: product id: 8709sc, serial #: (b)(4), product type: catheter. Other relevant device(s) are: product id: 8709sc, serial/lot #: (b)(4), ubd: 23-feb-2011, udi#: (b)(4). If information is provided in the future, a supplemental report will be issued.

Event Description

Information was received from a healthcare provider (hcp) regarding a patient who was receiving lioresal (2000mcg/ml at 351. 4mcg/day) via intrathecal drug delivery pump. The indication for use was noted as intractable spasticity. It was reported that the patient had a spinal fusion on (b)(6) 2018. It was unknown if this was related to the therapy. Shortly after, the patient was admitted to the intensive care unit (icu) because they were not able to get the pain under control. Around (b)(6) 2018 or (b)(6) 2018, the patient was tight, had a fever, and had tachycardia. The pump logs were checked; there were no issues with the pump. The hcp programmed a single bolus, the patient seemed to have a response; however, it was difficult to tell. An x-ray of the catheter was done, it showed there was a slight kink; however, this kink was "supposedly already there before the spinal fusion", per the hcp. 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 hcp. It was reported that the patient was still having similar issues ever since the spinal fusion. They wanted to check for a possible infection and tried to aspirate cerebrospinal fluid (csf) but had a difficult time doing so. The hcp was eventually able to get about 2ml of csf out, but could not get any more. It was confirmed that it was significantly more than the tubing volume. It was red-tinged, but the hcp was not sure if that was from accessing it or if the csf was truly red-tinged. The hcp was not sure if any of the patient's symptoms were related to the system or whatever had been going on since the spinal fusion. The patient had also had fevers up to (b)(6) but did not feel withdrawal symptoms would have lasted this long. The hcp used the tablet to program a bolus after the aspiration. The patient was not very stable to begin with but shortly after the bolus, the patient became hypotensive and bradycardic and they ended up intubating him. The patient was due for a refill soon. She had checked the volume shortly after the fusion after the patient started having symptoms and it matched. The hcp did not have much history on the patient so it was difficult to assess his response to things like boluses or dose changes. The current dose was 2000mcg/ml at 420mcg/day. 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 hcp. It was reported that the patient continued to have the same symptoms (intermittent periods of withdrawal). The patient responded positively to single bolus's they had aspirated fluid freely from the catheter access port (cap) but had not done a cap dye study. 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 an hcp via a manufacturer representative on 2019-apr-01. It was reported that they were doing a catheter revision on (b)(6) 2019 to try to fix the catheter issue. It was unknown if the catheter event had been confirmed, and they were hoping that once they opened the patient up, they could see a hole in the catheter and just revise that. No new patient symptoms were reported.

Manufacturer Narrative

Section 'device' information references the main component of the system and other applicable components are: product id: 8709sc, serial# (b)(4), explanted: (b)(6) 2019, 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 explanted and sent to pathology by the hcp. A hole was found in the spinal part of the catheter. There were no further complications reported at this time.

• 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: 8155938
• MDR Text Key: 130078659
• Report Number: 3004209178-2018-27474
• Device Sequence Number: 1
• Product Code: LKK
• 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,health

Reporter Occupation

• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 04/03/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/12/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes

Device Operator

• Device Expiration Date: 02/28/2017
• Device Model Number: 8637-20
• Device Catalogue Number: 8637-20
• 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 Received: 04/02/2019
• Was Device Evaluated by Manufacturer?: No Answer Provided
• Date Device Manufactured: 08/31/2015
• 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: 12/12/2018 Patient Sequence Number: 1