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

Model Number 8637-20

Device Problems Kinked (1339); Battery Problem (2885)

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

Event Date 11/01/2017

Event Type  Injury  

Manufacturer Narrative

The main component of the system and other applicable components are: product id: 8780, serial# (b)(4), implanted: (b)(6) 2016, product type: catheter.If information is provided in the future, a supplemental report will be issued.

Event Description

Information was received from a patient who was receiving dilaudid, unknown concentration at unknown dose via intrathecal drug delivery pump for non-malignant pain, fecal incontinence and gastrointestinal/pelvis floor.It was reported that the catheter event had been confirmed.Patient stated there was a kink in her catheter and was not sure what caused it.Patient was to follow up with healthcare professional (hcp).Patient stated the hcp was fixing this issue on the day after this report date.No symptoms were reported.No further complications were reported.

Manufacturer Narrative

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

Manufacturer Narrative

Analysis of the pump identified that there was under infusion with an undetermined root cause.Analysis of the catheter found that the sutureless connector was damaged at explant, with no significant anomalies: result code (b)(4) and conclusion code (b)(4) apply to the pump.Result code (b)(4) and conclusion code (b)(4) apply to the catheter.If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

At analysis, interrogation of the pump showed it was programmed to deliver hydromorphone (0.1mg/ml at 0.03497mg/day) and bupivicaine (5mg/ml at 1.7485mg/day).Analysis results were not available at the time of this report.A follow-up report will be sent when analysis is completed.If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

Product id 8780 lot# serial# (b)(4) implanted: (b)(6)2016 explanted: product type catheter.If information is provided in the future, a supplemental report will be issued.

Event Description

Additional information was received from the healthcare professional (hcp) on (b)(6)2019.It was reported that the date of surgery was (b)(6)2017.Preoperative antibiotic was listed as vancomycin, and bactrim os postoperatively.Preoperative and postoperative diagnosis included degenerative disc disease of lumbar spine with lumbar radiculopathy symptoms and nonfunctioning pain pump.The procedure included replacement of intrathecal catheter with tunneling for replacement of intrathecal pain pump system.The implant was an intrathecal catheter and flowonix pain pump battery.This patient is a pleasant (b)(6) year-old white female who was being treated for low back pain with lumbar radiculopathy symptoms with continued right hip pain.An intrathecal catheter dye study was performed and they found obstruction of the intrathecal catheter.She has been having continued pain recently and it was thought that her pain pump system was nonfunctioning.She has had problems with her pain pump battery.They were replacing her intrathecal pain pump system on (b)(6)2017.There were no complications.The pump was filled with 20 ml intrathecal hydromorphone/bupivacaine solution.They placed the pump in the pump pocket.They were able to freely withdraw clear csf through the side-port.The pump was interrogated and started at 0.035 mg per day of intrathecal hydromorphone/bupivacaine.The plan and disposition was to discharge the patient home later that day.They were to follow-up with her in 2 weeks.She and her family were counseled on side effects and risk of over sedation.If the patient has any side effects or signs or symptoms of oversedation she is to call the hcp in the pain clinic and also go to the nearest emergency room.There were no further complications reported/anticipated.

• 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: 7076243
• MDR Text Key: 93693416
• Report Number: 3004209178-2017-24722
• 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: consumer,health professional
• Reporter Occupation: Other
• Remedial Action: Modification/Adjustment
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 01/23/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/01/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/28/2017
• Device Model Number: 8637-20
• Device Catalogue Number: 8637-20
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/15/2018
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/17/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/05/2015
• 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: 83 YR