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

Model Number 8637-40

Device Problems Filling Problem (1233); Obstruction of Flow (2423); Infusion or Flow Problem (2964); Material Deformation (2976)

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

Event Date 07/06/2017

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 clinical study on (b)(6) 2019 regarding a patient receiving hydromorphone (2.5mg/ml at 0.8985 mg/day) and bupivacaine (10mg/ml at 3.594mg/day) via an implanted infusion pump.The indication for use was spinal pain.It was reported that on (b)(6) 2017 the patient was in clinic for a fill and the note stated that only 29ml of solution was able to be added to the pump reservoir due to the collapsing of the bellows in the pump.11mlwas discarded.On (b)(6) 2019 the patient wanted to get the pump replaced to utilize the full 40ml reservoir and extend refill intervals.A dye study was to be performed to confirm the catheter tip location before replacing the pump.No action had been taken at the time of report.The outcome was ongoing.The etiology indicated the event was related to the device or therapy and was not related to the implant procedure.No further complications were reported or anticipated.

Manufacturer Narrative

Patient code (b)(4) no longer applies.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 no 2019-jul-25.It was reported that the patient experienced increased pain and only 32ml could put into the pump on (b)(6) 2019.A dye study occurred on (b)(6) 2019 and the hcp was unable to freely aspirate.It was noted that it was very sluggish/partially occluded.The hcp was able to get enough drug and spinal fluid to do a prime with contrast and the contrast did follow up into the spine.Explant was planned on an unknown date, and had not been scheduled yet.There were no reported environmental, external, or patient factors that may have led or contributed to the event and the issue was unresolved at the time of report.The pump was infusing hydromorphone (5.0mg/ml at 1.9984mg/day) and bupivacaine (20.0mg/ml at 7.993mg/day) at the time of report.The patient's status was alive - no injury.

Manufacturer Narrative

The pump was returned, and analysis found the exterior pump to have a concave shield that affected in-vivo function with an undetermined root cause.The catheter was returned, and analysis found no significant anomaly.All previously reported conclusion, method, and result codes no longer apply to the event.If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

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

Event Description

Additional information received from a healthcare professional (hcp) via a clinical study indicated a catheter access port (cap) contrast study was abnormal as a dynamic kink was found in the catheter."ae" pumper infusion.The system required a catheter revision on (b)(6) 2018.No further complications were reported/anticipated.

Manufacturer Narrative

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.

Event Description

Additional information received from a healthcare professional (hcp) via a manufacturer representative (rep) and a clinical study reported that therapy was ineffective and more frequent refills.For at least the last year the patient¿s pump has only been able to receive 35 cc¿s of drug during refills.It wouldn't allow the clinician to refill all 40 cc¿s.They suspected an issue with the bellows and scheduled the patient for a replacement.When the surgeon removed the patient¿s pump, it was apparent the back side of the pump had a dent in it.Likely being the reason why they couldn't fill the pump.The patient didn't report any falls or any reason the pump would be dented in the back.The pump was replaced with a new pump.Also, the patient failed a catheter dye study before they re placed the pump, so the surgeon also replaced her catheter.It was noted the catheter was occluded.There were no environmental/external/patient factors that may have led or contributed to the issue.Troubleshooting included a catheter dye study performed on the catheter which failed.They couldn't aspirate.No known troubleshooting of the diminished pump reservoir capacity.Actions that were taken to resolve the issue included the pump and catheter were replaced on (b)(6) 2019.The product was returned to the manufacturer for analysis.The issue was resolved at the time of the report/resolved without sequelae on (b)(6) 2019 and the patient status was listed as ¿alive ¿ no injury.¿ the patient's weight was asked, but unknown.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: 8800152
• MDR Text Key: 151358572
• Report Number: 3004209178-2019-13744
• Device Sequence Number: 1
• Product Code: LKK
• UDI-Device Identifier: 00643169508156
• UDI-Public: 00643169508156
• 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: Physician
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 11/14/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/17/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/28/2017
• Device Model Number: 8637-40
• Device Catalogue Number: 8637-40
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/04/2019
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/13/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/07/2016
• 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: 72 YR
• Patient Weight: 71