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

Model Number 8637-20

Device Problems Fluid/Blood Leak (1250); Migration or Expulsion of Device (1395); Aspiration Issue (2883); Infusion or Flow Problem (2964)

Patient Problems Pain (1994); No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Manufacturer Narrative

Concomitant medical products: product id: 8780, serial# (b)(4), implanted: (b)(6) 2017, product type: catheter.Other relevant device(s) are: product id: 8780, serial/lot #: (b)(4), (b)(6), (b)(4).If information is provided in the future, a supplemental report will be issued.

Event Description

Information was received from a consumer via a device manufacturer representative regarding a patient receiving unknown medication and unknown concentration and dosage via an implantable infusion pump for the treatment of failed back surgery syndrome and spinal pain.It was reported that the patient had a dye study and the physician was unable to aspirate.Her device was then emptied of drug and saline was put in its place.The event date was unknown.The healthcare provider (hcp) was unable to aspirate but did push dye through, it appeared that there was a leak of dye at the catheter pump connection site.Some dye did go through catheter but very sluggish.There was no known environmental/external/patient factors that may have led or contributed to the issue.Roller study showed that the rollers moved.The issue was not resolved and patient status was alive without injury.No further complication was reported.

Manufacturer Narrative

Due to imdrf harmonization, any previously submitted device, method, result, and conclusion codes no longer apply to this event.If information is provided in the future, a supplemental report will be issued.

Event Description

Additional information received from the rep indicated that no surgical intervention had been planned.No further complication was reported.

Manufacturer Narrative

(b)(4).If information is provided in the future, a supplemental report will be issued.

Event Description

Additional information was received on 26-oct-2018 from the patient who reported that her pump was alarming periodically about every half hour.Per the patient, this had been going on for about a month now.The alarm was heard during the call and it sounded like the critical alarm.The patient stated that she was not concerned about the risk of withdrawal because the pump was currently empty.She was taking oral medication instead because her catheter had pulled out and she was waiting to see a surgeon to address it.She believed it was (b)(6) when it was determined that her catheter pulled out.The oral medications were managing her pain, but not as well as the pump did.Per the patient, the drug previously in the pump at the time the catheter issue occurred was a mixture of morphine and two other drugs.She did not know the drug names or concentrations or doses for any of them.No further complications have been reported as a result of this event.

Manufacturer Narrative

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

Manufacturer Narrative

Analysis of the implantable infusion pump s/n (b)(4) found no anomalies.Analysis of the implantable intrathecal catheter s/n (b)(4) found no anomalies.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): MEDTRONIC PUERTO RICO OPERATIONS CO.; road 31, km. 24, hm 4; ceiba norte industrial park; juncos PR 00777
• Manufacturer (Section G): MEDTRONIC PUERTO RICO OPERATIONS CO.; road 31, km. 24, hm 4; ceiba norte industrial park; juncos PR 00777
• Manufacturer Contact: lisa woodward clark ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635263920
• MDR Report Key: 7664378
• MDR Text Key: 113518203
• Report Number: 3004209178-2018-15077
• Device Sequence Number: 1
• Product Code: LKK
• UDI-Device Identifier: 00643169508149
• UDI-Public: 00643169508149
• 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,consum
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 07/12/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/05/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/28/2018
• Device Model Number: 8637-20
• Device Catalogue Number: 8637-20
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/02/2019
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 07/11/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/11/2017
• 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