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

Model Number 8637-20

Device Problems Break (1069); Disconnection (1171); Insufficient Information (3190)

Patient Problems Complaint, Ill-Defined (2331); No Known Impact Or Consequence To Patient (2692)

Event Type  Injury  

Manufacturer Narrative

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 who was receiving an unknown drug at unknown dose and concentration via intrathecal drug delivery pump.The indication for use was noted as chronic low back pain with intractable pain.It was reported that the patient recently had the pump replaced which was damaged from a previous injury to her pump site.No symptoms were reported.There were no further complications reported at this time.

Manufacturer Narrative

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

Manufacturer Narrative

Product id: 8780, serial# (b)(4), implanted: (b)(6) 2016, product type: catheter, ubd: 2018-08-29, udi: (b)(4).The previously reported patient, device, and evaluation conclusion codes no longer apply.If information is provided in the future, a supplemental report will be issued.

Event Description

Additional information was received from an hcp on 2018-aug-02.It was reported that the injury to pump site/pump damage was first noticed in (b)(6) 2017.The hcp was unsure if the pump itself was damaged, but the catheter became disconnected from the pump.It was clarified that the previous injury to the patient's pump site was caused by the patient's cow ramming his head into her abdomen over the pump.It was noted that the device or therapy did not cause, contribute to, or exacerbate the injury to the pump site that caused the damage to the pump.

• 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: 7681943
• MDR Text Key: 113781908
• Report Number: 3004209178-2018-15609
• 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: health professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 10/05/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/12/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/14/2011
• Device Model Number: 8637-20
• Device Catalogue Number: 8637-20
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/08/2018
• Date Device Manufactured: 03/23/2010
• 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 Weight: 65