MAUDE Adverse Event Report: MEDTRONIC NEUROMODULATION SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE

Model Number 8637

Device Problems Increase in Pressure (1491); Device Operates Differently Than Expected (2913); Activation Failure (3270)

Patient Problems Bacterial Infection (1735); Post Operative Wound Infection (2446)

Event Date 04/03/2018

Event Type  Injury  

Manufacturer Narrative

Concomitant medical products: product id: 8637, serial# unknown, product type: pump. Product id: neu_unknown_cath, lot# unknown, product type: catheter. Product id: 8637-20, serial# unknown, product type: pump. Information references the main component of the system. Other relevant device(s) are: product id: 8637, serial/lot #: unknown, ubd: , udi#:; product id: neu_unknown_cath, serial/lot #: unknown, ubd: , udi#:; product id: 8637-20, serial/lot #: unknown, ubd: , udi#:. Bartek j, jr. , skyrman s, nekludov m, mathiesen t, lind f, schechtmann g. Hyperbaric oxygen therapy as adjuvant treatment for hardware-related infections in neuromodulation. Stereotact funct neurosurg. 2018. Please note that this date is based off of the date of publication of the article, as the event dates were not provided in the published literature. If information is provided in the future, a supplemental report will be issued. [(b)(4)_lit. Pdf].

Event Description

Summary: in neuromodulation therapies, hardware-related infections are a major challenge often leading to hardware removal. A (b)(6)-year-old male patient with a diagnosis of cerebral palsy experienced a battery pocket infection (superficial surgical site infection) 10 days after exchange of their intrathecal baclofen pump. The pump was implanted in the subcutaneous tissue of the abdomen. Material was collected aseptically for aerobic and anaerobic bacterial cultures. A wound culture revealed the infection to be (b)(6). There was no surgical site revision. There was no implant explantation. The patient was treated with antibiotics and adjuvant hyperbaric oxygen therapy (hbot). Hyperbaric treatment was administered at 2. 0 to 2. 8 bars. The patient received clindamycin, dicloxacillin, or flucloxacillin. The time to infection resolution was 12 weeks. Long term infection control was achieved. This was considered a post-operative hardware-related infection. No further complications were reported or anticipated. A (b)(6)-year-old male patient with a diagnosis of cerebral palsy experienced a lower back incision infection (superficial incisional surgical site infection) 13 days after revision of the catheter and exchange of the intrathecal pump (baclofen). The pump was implanted in the subcutaneous tissue of the abdomen. No wound culture was taken. There was no surgical site revision. There was no implant explantation. The patient was treated with antibiotics and adjuvant hbot. Hyperbaric treatment was administered at 2. 0 to 2. 8 bars. The patient received clindamycin, dicloxacillin, or flucloxacillin. The time to infection resolution was 10 weeks. Long term infection control was achieved. This was considered a post-operative hardware-related infection. No further complications were reported or anticipated. A (b)(6)-year-old female patient with a diagnosis of neuropathic pain experienced an intrathecal pump pocket infection (superficial surgical site infection) 14 days after the implant of the intrathecal pump (baclofen). Material was collected aseptically for aerobic and anaerobic bacterial cultures. The wound culture was (b)(6). It was stated 1 surgical site revision was performed, but there was no implant explantation. A wound debridement or crust removal was performed. The patient was treated with antibiotics and adjuvant hyperbaric oxygen therapy (hbot). Hyperbaric treatment was administered at 2. 0 to 2. 8 bars. The patient received clindamycin, dicloxacillin, or flucloxacillin. The time to infection resolution was 12 weeks. Long term infection control was achieved. This was considered a post-operative hardware-related infection. No further complications were reported or anticipated. A (b)(6)-year-old female patient with a diagnosis of neuropathic pain experienced an intrathecal pump pocket infection (deep incisional surgical site infection) 30 days after the implant of the intrathecal pump (clonidine). A wound culture was not taken. There was no surgical site revision. There was no implant explantation. The patient was treated with antibiotics and adjuvant hyperbaric oxygen therapy (hbot). Hyperbaric treatment was administered at 2. 0 to 2. 8 bars. The patient received clindamycin, dicloxacillin, or flucloxacillin. The time to infection resolution was 10 weeks. Long term infection control was achieved. This was considered a post-operative hardware-related infection. No further complications were reported or anticipated. A (b)(6)-year-old male patient with a diagnosis of cerebral palsy experienced a catheter revision. No further complications were reported or anticipated. A (b)(6)-year-old male patient with a diagnosis of cerebral palsy experienced an intrathecal pump malfunction caused by hbot at 2. 8 bars. There was pump removal after the previously mentioned infection resolution. It was also stated this removal occurred 2 months after the end of hbot. The malfunction was caused by barotrauma resulting in an inadequate refilling capacity of the pump (14 ml instead of the normal 20 ml). It was not possible to fill the drug reservoir up to maximal capacity (20 ml). The healthcare provider (hcp) suspected that the air-filled reservoir had imploded or shrunk at the 2. 8 bar treatment pressure level. No further complications were reported or anticipated.

• Brand Name: SYNCHROMED II
• Type of Device: PUMP, INFUSION, IMPLANTED, PROGRAMMABLE
• Manufacturer (Section D): MEDTRONIC NEUROMODULATION; 800 53rd ave ne; minneapolis MN 55421 1200
• Manufacturer (Section G): MEDTRONIC NEUROMODULATION; 800 53rd ave ne; minneapolis MN 55421 1200
• Manufacturer Contact: lisa woodward clark ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635263920
• MDR Report Key: 7606886
• MDR Text Key: 111309800
• Report Number: 3007566237-2018-01799
• Device Sequence Number: 1
• Product Code: LKK
• Combination Product (y/n): N
• Reporter Country Code: SW
• PMA/PMN Number: P860004
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,l

Reporter Occupation

• Type of Report: Initial
• Report Date: 06/15/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/15/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes

Device Operator

• Device Model Number: 8637
• Device Catalogue Number: 8637
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 05/18/2018
• Was Device Evaluated by Manufacturer?: No Answer Provided
• 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: 06/15/2018 Patient Sequence Number: 1