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

Model Number 8637-20

Device Problems Device Operates Differently Than Expected (2913); Insufficient Information (3190)

Patient Problems Dyspnea (1816); Pain (1994); Therapeutic Response, Decreased (2271); Loss of consciousness (2418); Ambulation Difficulties (2544); No Known Impact Or Consequence To Patient (2692)

Event Date 04/26/2018

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 consumer regarding a patient receiving unknown drug via an implanted pump.The indication for use was spinal pain.It was reported the patient's new pain pump was not working.

Manufacturer Narrative

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

Event Description

Additional information received from a consumer reported the patient experienced the pump not working within the first two years between 2016-2017.It was noted the patient needed more medication for pain.The patient had to buy a scooter to move around because they couldn't walk.The patient also uses ice packs at all times.The patient's pain levels were at 10 and had to go to the emergency room.The patient stated the pump has been a disaster and had to change their life due to the uncontrolled pain.A myelogram dye study was performed in 2018 as well as ct scans, mri's, injections, etc in the previous years.It was unsure if the issue was resolved as the patient's pain was still at a 10 and still needed a back brace and ice packs all the time.The patient's weight was noted as (b)(6) to (b)(6).The patient had to sell their car as they could not drive or use a walker.It was noted the pain pump was ok in the beginning (2012) but each year the pump gave less pain relief.The patient was in and out of hospitals, ambulances, and the emergency room many times.Omitted information pertaining to (b)(4) pain; unable to aspirate, granuloma.

Manufacturer Narrative

The previously reported conclusion codes no longer apply to this event and have been updated.Patient codes have been updated to include (b)(4).If information is provided in the future, a supplemental report will be issued.

Event Description

On 2019-dec-02, additional information was received from the patient.It reported the patient was currently receiving dilaudid (unknown dose and concentration).The patient reported they just came out of the hospital for 10-12 days due to pain and stated their pump was not working.The patient went to the hospital because they couldn't breathe, turned purple and passed out.The patient stated they thought they were having a pulmonary stroke, but it turned out her symptoms were due to excruciating pain.The patient stated they were in the intensive care unit (icu) to manage their pain and was placed on oxygen.The patient stated they were given back-up medication.The patient also mentioned the symptom of incontinence.The patient stated they felt as though her pump has "never worked" since it was implanted.The patient provided all different timelines during the call when asked, but ultimately stated they have had issues since their pump was replaced on (b)(6) 2018.The patient mentioned they were given gel packs and ice packs for their pain.The patient would be going to their hcp office for their pump tomorrow via ambulance transport.

• 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: 7538309
• MDR Text Key: 109056758
• Report Number: 3004209178-2018-11678
• Device Sequence Number: 1
• Product Code: LKK
• UDI-Device Identifier: 00643169530119
• UDI-Public: 00643169530119
• 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
• Report Date: 12/26/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/23/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/28/2019
• Device Model Number: 8637-20
• Device Catalogue Number: 8637-20
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/02/2019
• Date Device Manufactured: 04/13/2018
• 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): Hospitalization; Life Threatening
• Patient Age: 68 YR
• Patient Weight: 83