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

Model Number 8637-40

Device Problems Migration or Expulsion of Device (1395); Retraction Problem (1536)

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

Event Date 07/23/2018

Event Type  Injury  

Manufacturer Narrative

Concomitant medical products: product id: 8578, lot# n304289013, implanted: (b)(6) 2012, explanted: (b)(6) 2018, product type: catheter.Product id: 8578, serial/lot #: (b)(4), ubd: 14-sep-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 professional (hcp) via the manufacturer representative (rep) regarding a patient who was receiving lioresal, 2000 mcg/ml concentration at 440 mcg/day dose via intrathecal drug delivery pump for unknown indication of use.It was reported that patient was undergoing normal replacement today for pump near elective replacement indicator (eri).It was discovered that catheter was retracted into pocket during surgery.No previous issues or loss of efficacy had been noted prior to replacement.Patient thought pump was working.Entire system was replaced including new ascenda catheter # n780778004.No environmental/external/patient factors that may have led or contributed to the issue were reported.No diagnostics/troubleshooting was performed.Catheter was replaced.At the time of this report, the issue had been resolved and patient status was alive-no injury.No further complications were reported.

Manufacturer Narrative

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.

Manufacturer Narrative

The pump was returned and analysis pump/motor/gear train anomaly/corrosion and-or wear and-or lubrication and pump/motor/gear tr ain anomaly/stall due to shaft-bearing.8578 catheter was returned and analysis found catheter/sc connector/coring-tears-cuts in seal/no leak seen in lab and no leak seen in lab and no leak allegation.The unknown catheter was returned and analysis found catheter/ miscellaneous/acceptable testing/catheter incomplete/returned in segments.If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

The main component of the system and other applicable components are: product id: 8578, lot# n304289013, implanted: (b)(6) 2012, explanted: (b)(6) 2018, product type: catheter; product id: neu_unknown_cath, lot# unknown, product type: catheter.Analysis results were not available at the time of this report.A follow-up report will be sent when analysis is completed.Eval code-method, results codes no longer apply.If information is provided in the future, a supplemental report will be issued.

Event Description

Additional information was received from a manufacturer representative.An additional catheter part was returned with no allegations of deficiencies related to the identity, quality, durability, reliability, safety, effectiveness, or performance of the device.There were no further complications reported at this time.

• 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: 7722507
• MDR Text Key: 115106800
• Report Number: 3004209178-2018-16700
• Device Sequence Number: 1
• Product Code: LKK
• 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: 10/03/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/26/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/14/2013
• Device Model Number: 8637-40
• Device Catalogue Number: 8637-40
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/27/2018
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/08/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/15/2011
• 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: 32 YR
• Patient Weight: 59