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U.S. Department of Health and Human Services

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

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MEDTRONIC NEUROMODULATION SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE Back to Search Results
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.
 
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Brand NameSYNCHROMED II
Type of DevicePUMP, 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 Key7606886
MDR Text Key111309800
Report Number3007566237-2018-01799
Device Sequence Number1
Product Code LKK
Combination Product (y/n)N
Reporter Country CodeSW
PMA/PMN Number
P860004
Number of Events Reported1
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 Received06/15/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model Number8637
Device Catalogue Number8637
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 Received05/18/2018
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
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