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

Model Number 8637-40

Device Problems Filling Problem (1233); Fluid/Blood Leak (1250); Device Operates Differently Than Expected (2913)

Patient Problems Abdominal Pain (1685); Abdominal Distention (2601); No Known Impact Or Consequence To Patient (2692)

Event Date 03/12/2017

Event Type  Injury  

Manufacturer Narrative

Concomitant medical products: product id: 8709, lot# j11274r20, implanted: (b)(6) 2002, 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) regarding a patient receiving unknown medication at unknown concentration and dosage via an implantable infusion pump for the treatment of spinal pain, non-malignant pain and failed back surgery syndrome.The pump was initially implanted with morphine for back pain.It was reported that the patient had a broken pump line.There was a leak in the line requiring surgical intervention.There was subsequent pocket failure and refill difficulty.The patient had experienced 8 months of abdominal pain and 2 months of abdominal distention.No further complication was reported.

Manufacturer Narrative

Intervention required was checked in error in the initial report.Serious injury was checked in error in the initial report.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 (hcp).It was reported that the surgery to remove the system was pending.No further complication was reported.

Manufacturer Narrative

Product id: 8709, lot# j11274r20, implanted: (b)(6)2002, explanted: (b)(6)2018, product type: catheter.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 device manufacturer representative.The pump and catheter was explanted on (b)(6) 2018.The cause of the broken pump line was unknown and the cause of pocket failure was unknown.Intervention was unknown and no further complication was reported.

• 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: 7334608
• MDR Text Key: 102244057
• Report Number: 3004209178-2018-04932
• Device Sequence Number: 1
• Product Code: LKK
• UDI-Device Identifier: 00643169100824
• UDI-Public: 00643169100824
• 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
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 05/24/2018

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: 06/28/2015
• Device Model Number: 8637-40
• Device Catalogue Number: 8637-40
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/12/2018
• Initial Date FDA Received: 03/13/2018
• Supplement Dates Manufacturer Received: 04/09/2018; 04/26/2018; 05/23/2018
• Supplement Dates FDA Received: 04/12/2018; 04/30/2018; 05/24/2018
• Date Device Manufactured: 01/02/2014
• 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: 68 YR