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

Model Number 8637-40

Device Problems Occlusion Within Device (1423); Pumping Stopped (1503); Aspiration Issue (2883); Device Operates Differently Than Expected (2913)

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

Event Date 02/10/2018

Event Type  Injury  

Manufacturer Narrative

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

Event Description

Information was received from a healthcare provider (hcp) via a company representative (rep) regarding a patient receiving intrathecal bupivacaine 0.2 mg/ml and unknown morphine 25 mg/ml (unknown doses) via an implanted pump for non-malignant pain and failed back surgery syndrome.A motor stall was seen at initial interrogation and the patient did not recently have a mri.The pump status and/or event log report showed a motor stall occurred (active) on (b)(6) 2018.There were no reported symptoms.No further complications were reported/anticipated or expected.

Manufacturer Narrative

Information references the main component of the system and other applicable components are: product id: 8709sc, serial# (b)(4), implanted: (b)(6) 2011, explanted: (b)(6) 2018, product type: catheter.Correction: updated the regulatory report with the device explant dates.If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

Information references the main component of the system and other applicable components are: product id: 8709sc, serial# (b)(4), implanted: (b)(6) 2011, product type: catheter.If information is provided in the future, a supplemental report will be issued.

Event Description

Additional information was received from a consumer via a device manufacturer representative, indicating that the patient experienced withdrawal symptoms and a motor stall had occurred, which was likely due to normal elective replacement indicator (eri).Interrogation of pump showed that a motor stall occurred in (b)(6) 2018.The pump and catheter were replaced.During replacement, the healthcare provider (hcp) was unable to aspirate the catheter.Upon inspection of the catheter, the hcp was unable to locate any obvious breaks or fractures.Upon further inspection, the hcp located the catheter tip, and noticed black precipitate.Once the tip of the catheter was cut off, the hcp was able to flush the catheter with saline.The catheter was replaced, and aspiration was successful.The issue was resolved at the time of the report.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 the healthcare provider (hcp) indicated someone (¿illegible¿) called monday (b)(6) 2018 in pm about the patient.The patient was going through withdrawal symptoms.It was noted ¿illegible¿ on (b)(6) 2018 at 10.The pump was read ¿illegible¿ motor stall on (b)(6) 2018 at 06:05.The pump med aspirated.Chamber air aspirated.Saline wash done x2, pump refill done.Motor stall confirmed.¿illegible¿ repeated again without success and tried to access catheter access port (cap).It was noted no cerebrospinal fluid (csf) aspirated.Therefore, two attempts done to give single bolus ¿illegible.¿ the motor stall did not recover.Actions/interventions included a pump wash x 1, cap aspiration x2, no ¿illegible,¿ prime bolus with saline x2 with no success.The motor stall was resolved (the pump was replaced).The patient¿s weight at the time of the event was (b)(6).Additional information/clarification was requested regarding the eligible wording; however, a response has not been received at this time.Additional information was received from a company representative (rep) indicated the pump would be returned.However; pump was currently at the hospital account pathology department.They are to reach out to the rep when the pump is available to be returned.No further complications were reported/anticipated or expected.

Manufacturer Narrative

Product id: 8709sc, (b)(4), implanted: (b)(6)2011, explanted: (b)(6)2018, product type: catheter.Other relevant device(s) are: product id: 8709sc, lot #: n280410013, ubd: (b)(4)2013, udi#: (b)(4).If information is provided in the future, a supplemental report will be issued.

• 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: 7270286
• MDR Text Key: 100131040
• Report Number: 3004209178-2018-03295
• 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,consum
• Reporter Occupation: Physician
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 04/16/2018

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: 04/14/2013
• Device Model Number: 8637-40
• Device Catalogue Number: 8637-40
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/13/2018
• Initial Date FDA Received: 02/14/2018
• Supplement Dates Manufacturer Received: 02/17/2018; 02/17/2018; 02/16/2018; 04/16/2018
• Supplement Dates FDA Received: 02/19/2018; 02/19/2018; 03/09/2018; 04/16/2018
• Date Device Manufactured: 10/21/2011
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: Z-0497-2013
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 60 YR
• Patient Weight: 91