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

Model Number 8637-40

Device Problems Premature Elective Replacement Indicator (1483); Adverse Event Without Identified Device or Use Problem (2993); Appropriate Term/Code Not Available (3191)

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

Event Date 07/10/2018

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 healthcare provider (hcp) via a manufacturer representative 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 spinal pain. It was reported that the manufacturer representative received an email on (b)(6) 2018 from the clinic that at the appointment on (b)(6) 2018 with the pump refill, the expected reservoir volume (erv) was 10ml and the actual reservoir volume (arv) was 14ml. Also, elective replacement indicator (eri) had occurred on (b)(6) 2018, which was unexpected and the hcp was surprised about that because nothing was done with the pump at the last refill in (b)(6) 2018 and there was 26 months left for the eri at that time. No symptoms were reported. There were no further complications reported at this time.

Manufacturer Narrative

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

Event Description

Additional information was received from the manufacturer representative. It was reported that the pump was replaced on (b)(6) 2018. There were no further complications reported at this time.

Manufacturer Narrative

The main component of the system and other applicable components are: product id: 8780, serial#: (b)(4), implanted: (b)(6) 2013, explanted: (b)(6) 2018, product type: catheter. Analysis results were not available at the time of this report. A follow-up report will be sent when analysis is completed. If information is provided in the future, a supplemental report will be issued.

Event Description

Additional information was received from a manufacturer representative. The pump was delivering morphine (25 mg/ml at 17. 389 mg/day) and clonidine (1100 mcg/ml at 765. 1 mcg/day). The infusion pump was returned. The catheter was also returned with no allegations of deficiencies related to the identity, quality, durability, reliability, safety, effectiveness, or performance of the device. There were no further complications reported at this time.

Manufacturer Narrative

Analysis of the implantable pump (serial # (b)(4)) identified the start of electromigration across the electrical feed-through insulator along with moisture being present on the insulator. However, an electrical short was not observed during function testing in the laboratory. Analysis identified the pump had reached eri due to voltage, however could not determine the cause. Analysis of the implantable catheter (serial # (b)(4)) identified tearing to the transition tubing. H6 - eval code-method 4118 no longer applies eval code-result 3233 no longer applies. Eval code-conclusion 11 no longer applies. If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

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

Manufacturer Narrative

(b)(4). 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): 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: 7694776
• MDR Text Key: 114287588
• Report Number: 3004209178-2018-15935
• 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: company representative,health

Reporter Occupation

• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 10/30/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/17/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes

Device Operator

• Device Expiration Date: 03/14/2015
• Device Model Number: 8637-40
• Device Catalogue Number: 8637-40
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/15/2018
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 10/30/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/18/2013
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial

Patient Treatment Data

Date Received: 07/17/2018 Patient Sequence Number: 1