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

Model Number 8637-40

Device Problems Fluid/Blood Leak (1250); Migration or Expulsion of Device (1395); Failure to Disconnect (2541); Detachment of Device or Device Component (2907); Infusion or Flow Problem (2964); Positioning Problem (3009)

Patient Problems No Known Impact Or Consequence To Patient (2692); No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

Product id: 8780, serial# (b)(4), implanted: (b)(6) 2015, product type: catheter.Other relevant device(s) are: product id: 8780, serial/lot #: (b)(4), ubd: (b)(6) 2017, udi#: (b)(4).If information is provided in the future, a supplemental report will be issued.

Event Description

Information was provided by a manufacturer¿s representative regarding an implantable intrathecal pump intended to deliver bupivacaine and morphine (concentrations and doses unknown, indicated for post lumbar laminectomy syndrome and spinal pain.It was reported that during a pump revision, when the surgeon went to try to take off the sutureless connector he pulled back and the white came apart from the metal.They then put on a new catheter.After hooking up they were only able to get about 0.4 ml from the catheter so they put some omipaque dye through the catheter and there was a "puddle" of the dye and it was not intrathecal.The surgeon took the pump out and cut the existing catheter and tied it off.No patient symptoms were reported.The event date was unknown; the catheter issue was discovered on (b)(6) 2018, but they were unsure if it was caused by something done during the revision on (b)(6) 2018, or if it was pre-existing, since the patient had not reported any issues with therapy.It was stated that the plan is to bring the patient back in the next couple of weeks to put in a new catheter and pump.It was noted that the pump would not be returned for analysis as there was no allegation of a problem with the pump.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 a company representative (rep) indicated the doctor put in a new 8780 catheter and new (b)(4) pump on (b)(6) 2018.It was noted he left the existing portion of the catheter inside the patient.No further complications were reported/anticipated or expected.

Manufacturer Narrative

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

Event Description

The pump was intended to deliver bupivacaine [20 mg/ml] at 4.4 mg/day and morphine [2 mg/ml] at 0.44 mg/day.Reference regulatory report #3004209178-2018-15767 for the manufacturer's report regarding the reason for the revision.

Manufacturer Narrative

(b)(4).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 was received from the healthcare provider on (b)(6) 2018.Regarding the cause of the catheter being outside of the intrathecal space, the healthcare provider provided the following information.The catheter was revised because the attempt to aspirate cerebrospinal fluid (csf) was not successful and contrast was injected and did not show spread.The patient wanted the pump site revised and preferred the opposite side, which was not the original plan.It was indicated the plan was to revise the pocket.The decision was made to explant.The following week the pump and catheter were implanted on the opposite (right) side.

Manufacturer Narrative

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

Manufacturer Narrative

Section 'device' information refers to the main device.The other relevant component includes: product id: 8784, serial# (b)(4), implanted: (b)(6) 2018, explanted: (b)(6) 2018, product type: catheter; ubd: 04/26/2020, udi#: (b)(4), device code (b)(4) no longer applies to this event.Code-conclusion applies to catheter product id 8780, serial# (b)(4), and code-conclusion applies to catheter, product id 8784, serial# (b)(4).If information is provided in the future, a supplemental report will be issued.

Event Description

Additional information was received from a healthcare provider (hcp) via a company representative (rep).It was reported the 8784 was not implanted due to the pooling of dye.The catheter was explanted along with the pump on (b)(6) 2018.Additional information was received from the company rep (rep).It was reported the 8784 catheter was not implanted, therefore it was not registered for the patient.The serial number of the 8784 was provided.Additional information was received from the company rep (rep).The rep confirmed that the revision was performed on (b)(6) 2018.When the doctor went to remove the sutureless connector, he pulled back and the white part of the sc connector separated from the metal part.Therefore, the doctor planned to implant a new 8784 catheter.However, once the new catheter was attached, the doctor was only able to get about 0.4 mls from the catheter, so dye was put through the catheter and pooling of dye was observed with the new 8784 catheter.The pump was then removed, and a portion of the original 8780 catheter was tied off and left in the patient.It was undetermined what caused the pooling of dye.A new system was implanted on (b)(6) 2018, which resolved the issue.The catheter segments were discarded.

Event Description

Additional information was received from a healthcare provider (hcp) via a company representative (rep) indicated the explanted portion of the catheter was discarded by the hcp and would not be returned for analysis.Per the hcp, the cause of the inability to aspirate after the hooking up the new catheter and pooling dye during the revision was not determined.The patient was doing well post replacement of the catheter and pump.No further complications were reported/anticipated or expected.

Manufacturer Narrative

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): MEDTRONIC PUERTO RICO OPERATIONS CO.; road 31, km. 24, hm 4; ceiba norte industrial park; juncos PR 00777
• MDR Report Key: 7687809
• MDR Text Key: 114008564
• Report Number: 3004209178-2018-15763
• Device Sequence Number: 1
• Product Code: LKK
• UDI-Device Identifier: 00643169100824
• UDI-Public: 00643169100824
• Combination Product (y/n): N
• PMA/PMN Number: P860004
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 10/05/2018

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: 09/14/2016
• Device Model Number: 8637-40
• Device Catalogue Number: 8637-40
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 07/10/2018
• Initial Date FDA Received: 07/13/2018
• Supplement Dates Manufacturer Received: 07/13/2018; 07/20/2018; 07/30/2018; 08/12/2018; 08/12/2018; 08/17/2018; 08/08/2018
• Supplement Dates FDA Received: 07/13/2018; 07/24/2018; 08/02/2018; 08/13/2018; 08/13/2018; 08/20/2018; 10/05/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Weight: 92