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

Model Number 8637-20

Device Problems Occlusion Within Device (1423); Obstruction of Flow (2423); Aspiration Issue (2883); Device Operates Differently Than Expected (2913); Infusion or Flow Problem (2964); Insufficient Information (3190)

Patient Problems Pain (1994); Therapeutic Effects, Unexpected (2099)

Event Date 05/26/2017

Event Type  Injury  

Manufacturer Narrative

Other applicable components are: product id: 8711, lot# j11153r44, implanted: (b)(6) 2002, product type: catheter.Product id: 8711, lot# j10949r16, implanted: (b)(6) 2001 product type: catheter.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 regarding a patient receiving fentanyl (50.0 mcg/ml at 10.992 mcg/day) and bupivacaine (10.0 mg/ml at 2.198 mg/day) via an implantable infusion pump.The indication for use was noted as non-malignant pain.It was reported the patient reported unsatisfactory analgesia on (b)(6) 2017.The subject stated that they felt the pump did not work well for about 5 days.The subject manipulated the catheter at the right flank and felt like it got caught.No action was taken as an intervention.The event resulted in an unscheduled clinic or office visit.The device diagnosis was possible catheter malfunction.The outcome was resolved without sequelae on (b)(6) 2017.It was further reported that the cause of the unsatisfactory analgesia was a possible catheter malfunction.The etiology was noted as possibly related to the device or therapy and not related to the implant procedure.No further complications were anticipated/reported.

Manufacturer Narrative

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

Event Description

It was further noted that a catheter revision and pump replacement were ordered for (b)(6) 2018, but these actions were not initially reported.

Manufacturer Narrative

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

Event Description

Additional information was received from a healthcare provider via a clinical study on 2018-feb-23.It was reported that the malfunction was not confirmed.

Manufacturer Narrative

Concomitant medical products: product id: 8711, lot# j11153r44, implanted: (b)(6) 2002, explanted: (b)(6) 2018, product type: catheter, (b)(6); (b)(4).Analysis results were not available as of the date of this report.A follow-up report will be submitted when analysis is complete.If information is provided in the future, a supplemental report will be issued.

Event Description

Additional information was received from a healthcare provider via clinical study on 2018-apr-06.It was reported that the catheter was unable to be aspirated at the time of the dye study.The back incision was surgically opened and the spinal catheter was disconnected from the pump catheter.It was noted that there was no cerebrospinal fluid (csf) flow, and the spinal catheter was occluded.The spinal catheter was removed and replaced on (b)(6) 2018.It was indicated that the inability to aspirate the catheter occurred on (b)(6) 2018, and the catheter occlusion was identified on (b)(6) 2018.It was indicated the pump was removed prophylactically to avoid in-vivo battery depletion, on the same date the catheter was replaced, and the patient recovered without sequelae.

Manufacturer Narrative

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

Event Description

Additional information was received from a healthcare provider via a clinical study on (b)(6) 2018.It was reported that the outcome was ongoing.

Manufacturer Narrative

Concomitant medical products: product id: 8711, lot# j11153r44, implanted: (b)(6) 2002: product type: catheter.Product id: 8711,lot# j10949r16, implanted: (b)(6) 2001, product type: catheter.(b)(4).Due to imdrf harmonization, some previously submitted device, method, result, and conclusion codes related to this event may have been updated.If information is provided in the future, a supplemental report will be issued.

Event Description

Additional information received from a healthcare provider via a clinical study reported the patient's entire system was explanted/replaced on (b)(6) 2018-.The device disposition was unknown.The issue resolved without sequelae on (b)(6) 2018.

Manufacturer Narrative

Concomitant product(s): product id: 8711, lot# j11153r44, implanted: (b)(6) 2002, product type: catheter.Product id: 8711, lot# j10949r16, implanted: (b)(6) 2001, product type: catheter.The catheter was returned, and analysis found the metal pin detached from the catheter tip and a hole cause by a deep abrasion on the catheter body.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.

• 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: 7248304
• MDR Text Key: 99239305
• Report Number: 3004209178-2018-02248
• 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: health professional,study
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 10/04/2018

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: 11/28/2014
• Device Model Number: 8637-20
• Device Catalogue Number: 8637-20
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/06/2018
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/16/2018
• Initial Date FDA Received: 02/07/2018
• Supplement Dates Manufacturer Received: 02/23/2018; 02/23/2018; 04/06/2018; 04/16/2018; 06/14/2018; 07/18/2018; 08/08/2018
• Supplement Dates FDA Received: 02/26/2018; 02/26/2018; 04/13/2018; 04/18/2018; 06/21/2018; 07/18/2018; 10/04/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/12/2013
• 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: 62 YR
• Patient Weight: 107