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

Model Number 8637-20

Device Problems Filling Problem (1233); Migration or Expulsion of Device (1395); Battery Problem (2885); Insufficient Information (3190)

Patient Problems Nausea (1970); Pain (1994); Burning Sensation (2146); No Known Impact Or Consequence To Patient (2692)

Event Date 04/01/2017

Event Type  Injury  

Manufacturer Narrative

Event date is an estimate.If information is provided in the future, a supplemental report will be issued.

Event Description

Information was received from a patient who was receiving dilaudid at an unknown concentration and dose via intrathecal drug delivery pump for non-malignant pain and failed back surgery syndrome.It was reported that the patient wanted to know if she had a recalled pump inside her, and was redirected to the healthcare provider (hcp) for more information.It was reported that the pump broke inside the patient, that the pump shorted out or the battery went kaput, that the pump was not working and they could not fill it with medication; the hcp was supposed to get a hold of the manufacturer to either fix it or remove it.The patient would follow up with the hcp.There were no reported symptoms.No further complications were reported.

Manufacturer Narrative

Concomitant medical products: product id: 8709, serial# (b)(4), implanted: (b)(6) 2006: product type: catheter.If information is provided in the future, a supplemental report will be issued.

Event Description

Additional information was received from the consumer indicated that due to the scar tissue that was discovered during her last magnetic resonance imaging (mri) that is on the hardware in her spine no healthcare provider (hcp) will remove or replace the pump.It was reported that the "strapping" holding the pump had busted so the pump moves around into her intestines and down to her hip.The caller reported that she felt burning where the pump was and thought it was causing her to be nauseated or unable to keep food down.A critical alarm was noted to be going off.The caller was sent a hcp listing.No further complications have been reported as a result of this event.

Manufacturer Narrative

Correction was made to this field; the previous report date on follow up 001 was incorrect.Concomitant medical products: product id: 8709, serial# (b)(4), implanted: (b)(6) 2006: product type: catheter.If information is provided in the future, a supplemental report will be issued.

Event Description

Additional information was received from the patient reporting that they have had nothing but problems with the pump since the day they got it.Patient stated the pump was defective and does not work.Patient stated the pump nearly killed them when it blew up inside of them.Patient mentioned the back pieces have fused in their spine and are covered in the system and didn't even show up on x ray anymore, it's just shadows.Patient also mentioned the pump has eaten through the sack the pump was in, and was bouncing all over their belly and causing them immense pain and today it was on fire and they just want it out of them.Patient stated they had dilaudid in the pump before the hcp put saline in the pump.

Manufacturer Narrative

Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.

• 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: justin ellis ; 8200 coral sea street ne mvs21; mounds view, MN 55112 ; 7635265677
• MDR Report Key: 7074906
• MDR Text Key: 93819480
• Report Number: 3004209178-2017-24687
• Device Sequence Number: 1
• Product Code: LKK
• UDI-Device Identifier: 00613994779229
• UDI-Public: 00613994779229
• 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: Consumer
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 08/01/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/14/2013
• Device Model Number: 8637-20
• Device Catalogue Number: 8637-20
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 11/30/2017
• Initial Date FDA Received: 12/01/2017
• Supplement Dates Manufacturer Received: 06/18/2018; 06/18/2019; 07/23/2024
• Supplement Dates FDA Received: 06/19/2019; 06/20/2019; 08/01/2024
• Date Device Manufactured: 11/15/2011
• 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
• Treatment: "SEE H10...."; "SEE H10...."
• Patient Outcome(s): Other
• Patient Age: 53 YR
• Patient Sex: Female