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

Model Number 8637-40

Device Problems Aspiration Issue (2883); Device Operates Differently Than Expected (2913); Infusion or Flow Problem (2964); Material Integrity Problem (2978); Patient Device Interaction Problem (4001)

Patient Problems Itching Sensation (1943); Pain (1994); Swelling (2091); Tingling (2171); Therapeutic Response, Decreased (2271)

Event Date 06/15/2018

Event Type  Injury  

Manufacturer Narrative

Continuation of medical devices: product id 8731sc, serial# (b)(4), implanted:(b)(6) 2012, product type catheter.Information references the main component of the system.Other relevant device(s) are: product id: 8731sc, serial/lot #: (b)(4), ubd: 11-aug-2013, udi#: (b)(4).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 device manufacturer representative regarding a patient receiving lioresal(2000 mcg/ml, 444 mcg/day) via an implantable infusion pump for the treatment of intractable spasticity and spinal cord injury/spinal cord disease.It was reported that the patient had the pump replaced on (b)(6) 2018.The healthcare provider (hcp) removed the water in back table and did not fill the pump or do a back table prime.They then placed the pump in, connected the pump to existing catheter and then closed up the patient.A resident access the reservoir at the fresh wound and fill the pump up.They then did a full system prime.The patient was sent home without being monitored.During the same evening, the patient started experiencing itchiness and stated the emergency room healthcare provider (hcp) had provided him with a 100 mcg bolus and also sent patient home with 60 mg of oral baclofen.The patient felt better and then things went bad again.The patient went to hcp's office on (b)(6) 2018 and was presented with pain in legs, paresthesia, and itchiness.The hcp would check reservoir and perform a catheter dye study on (b)(6) 2018.The representative was questioning what had really happened during the implant.The hcp did recall puffiness at the sight of the pump so she was questioning whether there was a pocket fill.A second concern was that interrogation showed the patient was implanted with an 8781 however in the system it was listed as 8731sc.A third concern was that the full system prime including the 0.14 ml of the inner pump tubing might have been too little to prime which could have potentially led to the withdrawal.It was reviewed that 0.14 was automatically chosen.However, the patient should be monitored.The representative had check and confirmed the programming was correct.It was later reported that the patient had a catheter revision.The hcp accessed the cap of the pump and was able to aspirate 1cc of clear fluid and was going to attempt a dye study but was unable to push dye through the cap.He opened the pump pocket over the connector and disconnected the pump connector.There was bloody material in the connector which the hcp cleaned out and then flushed the cap with saline.The hcp aspirated 1 cc of fluid again from the cap but was unable to push any dye through the cap.He decided to open the pump pocket further and noticed the catheter was broke.The hcp revised the proximal/pump end of the catheter and attached a new pin with collets, splicing the two sections of catheter together.There was talk about giving the patient a 100mcg bolus at this time but the managing hcp decided against it.The patient would be monitored in the hospital.Additional information received on (b)(6) 2018 suggested that the patient was still experiencing itching but not significant it had not been 24 hours since she had been getting the full dosage after catheter revision.Patient had also stated that her legs felt much better and were loose, but her feet were still hurting.Medication dosage remained at 444 mcg/day.No further complication was reported.

Manufacturer Narrative

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

Event Description

Additional information received from the representative indicated that pump was replaced due to normal battery depletion.No further complication was reported.

Manufacturer Narrative

Continuation of d11: product id 8731sc lot# serial# (b)(4) implanted: 2012-(b)(6) explanted: 2018-(b)(6) product type catheter: due to imdrf harmonization, any previously submitted device, method, result, and conclusion codes no longer apply to this event.If information is provided in the future, a supplemental report will be issued.

Event Description

The device was returned with no new information.Additional information was received from the healthcare provider (hcp) via a device manufacturer representative.It was reported that the hcp only aspirated one time and got back 1 cc instead of two times.After the hcp spliced the new catheter to the old catheter in pump pocket, the surgeon was still unable to push dye so he opened up the back area at the connector in back.He then cut off the entire catheter at the connector and attached the new pump segment to the old spine segment.The hcp was able to push dye and do a myelogram at the time of the report.No further complication was reported.

Manufacturer Narrative

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

Manufacturer Narrative

Concomitant medical products: product id neu_ascenda_cath serial# unknown explanted: (b)(6) 2018.Product type catheter product id neu_ascenda_cath serial# unknown explanted: (b)(6) 2018.Product type catheter concomitant medical products: there was no complaint on catheter 8731sc.Device evaluated by mfr: analysis found damage to transition tube and catheter body kink observed.Medtronic, inc.(medtronic) is submitting this report to comply with 21 c.F.R.Part 803, the medical device reporting regulation.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information in the time allotted and has provided as much information as is available to the company as of the submission date this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic or its employees caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any "defects" or has "malfunctioned".These words are included in the fda 3500a form and are fixed items for selection created by the fda, to categorize the type of event solely for the purpose of reporting pursuant to part 803.Medtronic objects to the use of these words and others like it because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.A good faith effort will be made to obtain the applicable information relevant to the report.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: 7658688
• MDR Text Key: 113025926
• Report Number: 3004209178-2018-14884
• Device Sequence Number: 1
• Product Code: LKK
• UDI-Device Identifier: 00643169530126
• UDI-Public: 00643169530126
• 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: 10/03/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/03/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/14/2019
• Device Model Number: 8637-40
• Device Catalogue Number: 8637-40
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/03/2018
• Date Manufacturer Received: 08/08/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 41 YR