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

Model Number 8637-20

Device Problems Occlusion Within Device (1423); Volume Accuracy Problem (1675); Aspiration Issue (2883); Device Operates Differently Than Expected (2913)

Patient Problems Cerebrospinal Fluid Leakage (1772); Pain (1994); Therapeutic Response, Decreased (2271)

Event Date 04/01/2018

Event Type  Injury  

Manufacturer Narrative

The main component of the system.Other relevant device(s) are: product id: 8780, serial/lot #: (b)(4), ubd: (b)(6) 2018, 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) regarding a patient who was receiving an unknown drug at an unknown dose and concentration via an implantable pump for non-malignant pain.It was reported that the patient's pump was not working.It was then clarified that they believed the catheter was kinked and the patient was in pain because of this.An mri was being done for the spine pain the patient was experiencing.The event date was noted to be "a few days ago".It was thought the drug in the pump was morphine and the patient's id card showed the calibration constant being 109cc, but the hcp was not certain.No further issues were reported or anticipated.

Manufacturer Narrative

Concomitant medical products: product id: 8780, serial# (b)(4), implanted: (b)(6) 2016, explanted: (b)(6) 2018, product type: catheter.If information is provided in the future, a supplemental report will be issued.

Event Description

Additional information was received form the consumer.It was reported that the patient had not been receiving medication for more than a week and went into withdrawal which was considered as a sudden change in therapy/symptoms.The healthcare provider (hcp) was concerned that the pump malfunctioned along with catheter and mentioned everything was not working.The pump did not alarm however expected reservoir volume (erv) was 14.7 ml while actual reservoir volume (arv) was 17 ml.The pump and catheter was replaced the day before (b)(6) 2018.During replacement, the physician was unable to aspirate from the cap or directly from the catheter.No further complication was reported.

Manufacturer Narrative

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

Event Description

Additional information was received from a consumer.It was reported that the patient's pump and catheter were removed due to malfunction, and "the reason is different depending on who you ask." the patient wanted to find out what happened with the pump, and requested that the manufacturer not destroy it after interrogation.The patient reported the pump malfunctioned and that she was going through withdrawal and rapid detox.The pump was at the hospital at the time of the report and they were going to do testing on it.The patient presented to the emergency room (er) on (b)(6) 2018 or (b)(6) 2018.The patient stated she "don't know anything" and everyone was giving her different answers.The patient requested access to the pump.Additional information was received from a healthcare provider (hcp).It was reported that the cause of the inability to aspirate was a catheter blockage.A revision was performed, and the inability to aspirate was resolved.No further complications were reported.

Manufacturer Narrative

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

Event Description

Additional information was received from a healthcare professional (hcp).It was reported that the patient had a cerebrospinal fluid (csf) leak and they were going to program the pump to off state.It was noted the pump was to be explanted at a later date.No further issues were reported or anticipated.

Manufacturer Narrative

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

Event Description

Additional information was received from a manufacturer's representative (rep).It was reported that the pump was explanted and was to be returned for analysis.

Manufacturer Narrative

Analysis determined a kink was observed.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: 7445073
• MDR Text Key: 106145898
• Report Number: 3004209178-2018-08441
• 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: consumer,health professional
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 08/23/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/14/2018
• Device Model Number: 8637-20
• Device Catalogue Number: 8637-20
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/19/2018
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/18/2018
• Initial Date FDA Received: 04/19/2018
• Supplement Dates Manufacturer Received: 04/24/2018; 04/23/2018; 05/04/2018; 06/14/2018; 08/22/2018
• Supplement Dates FDA Received: 04/25/2018; 05/02/2018; 05/11/2018; 06/15/2018; 08/23/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/17/2016
• 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: 47 YR
• Patient Weight: 77