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

Model Number 8637-40

Device Problems Occlusion Within Device (1423); Volume Accuracy Problem (1675); Device Operates Differently Than Expected (2913)

Patient Problems Granuloma (1876); Pain (1994); Therapeutic Response, Decreased (2271); No Known Impact Or Consequence To Patient (2692)

Event Date 11/18/2017

Event Type  Injury  

Manufacturer Narrative

Product id: neu_unknown_cath, serial# unknown, product type: catheter.Other relevant device(s) are: product id: neu_unknown_cath, serial/lot #: unknown.If information is provided in the future, a supplemental report will be issued.

Event Description

Information was received from a consumer regarding a patient with a drug infusion device.The drug being delivered was withheld.The reason for use was spinal pain.It was reported that the patient needed to have surgery done and they need to do a magnetic resonance imaging (mri).The caller stated that the mri was related to the pump because the pump was not working and the catheter is blocked.The caller stated that they need to figure out what is going on by doing a mri.The caller stated that the pump is suspended for 3 months, so didn¿t have drug information.The caller wanted to know what the limit was for having a mri or two mri¿s.It was stated that the center was ¿fearful of doing two mri.¿ it was reviewed that the center should call technical services.The event date was listed as 2017, ¿6 months ago.¿ the current managing healthcare professional (hcp) had the most information regarding this event.There were no further complications reported/anticipated.

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 on 2018-may-31.It was reported that a possible catheter tip granuloma was diagnosed.The patient was scheduled for a replacement of their pump, catheter and a possible granuloma removal on (b)(6) 2018.The issue was not considered resolved.It was unknown if there were any environmental,external or patient factors which may have led or contributed to the issue.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.

Manufacturer Narrative

(b)(4).If information is provided in the future, a supplemental report will be issued.

Event Description

Additional information was received from the manufacturer¿s representative (rep) on 2018-jun-05.The drugs being delivered were 10 m g/ml hydromorphone at 0.48mg, 100 mcg/ml clonidine at 4.8mcg, and 0.9 mg/ml bupivacaine at 0.04322mg.On (b)(6) 2018, the patient had the pump and catheter replaced.Per procedural hcp, there was no end tip granuloma suspected/seen on imaging.There was no cerebrospinal fluid (csf) return found intra-operative from the catheter.The patient stated he had return of pain approximately 6 months ago.He mentioned a pump refill and dye study.The rep confirmed dates and results of these appointments at managing hcp office on 2018-jun-06.The patient had a pump refill on (b)(6) 2018 with 10 ml¿s of medication removed from pump while 6.4 ml was expected.On (b)(6) 2018, the doctor did a dye study, and reported 0.2 ml aspirated and the dye injectated with no extravasation in the intrathecal space, then the patient was referred for the replacement.The explants were discarded and there was no request for return from the hcp.The patient¿s weight was reported and their past related medical history was unknown.

• 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: 7542117
• MDR Text Key: 109181632
• Report Number: 3004209178-2018-11825
• Device Sequence Number: 1
• Product Code: LKK
• UDI-Device Identifier: 00643169100824
• UDI-Public: 00643169100824
• 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
• Report Date: 06/27/2018

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: 03/28/2016
• Device Model Number: 8637-40
• Device Catalogue Number: 8637-40
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 05/18/2018
• Initial Date FDA Received: 05/24/2018
• Supplement Dates Manufacturer Received: 05/31/2018; 06/05/2018; 06/05/2018
• Supplement Dates FDA Received: 06/04/2018; 06/20/2018; 06/27/2018
• Date Device Manufactured: 10/07/2014
• 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: 56 YR
• Patient Weight: 75