BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN_PUMP

    MDR report key: 3773632 · Received April 25, 2014

    Report

    Report Number
    3007566237-2014-01150
    Event Type
    Injury
    Date Received
    April 25, 2014
    Report Date
    April 11, 2014
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID NEU_UNKNOWN_CATH, LOT# UNKNOWN, PRODUCT TYPE CATHETER; PRODUCT ID NEU_ UNKNOWN_PUMP, SERIAL# UNKNOWN, PRODUCT TYPE PUMP; PRODUCT ID NEU_UNKNOWN_PUMP, SERIAL# UNKNOWN, PRODUCT TYPE PUMP; PRODUCT ID NEU_UNKNOWN_CATH, LOT# UNKNOWN, PRODUCT TYPE CATHETER; PRODUCT ID NEU_UNKNOWN_CATH, LOT# UNKNOWN, PRODUCT TYPE CATHETER; PRODUCT ID NEU_UNKNOWN_CATH, LOT# UNKNOWN, PRODUCT TYPE CATHETER; PRODUCT ID NEU_UNKNOWN_CATH, LOT# UNKNOWN, PRODUCT TYPE CATHETER; PRODUCT ID NEU_UNKNOWN_CATH, LOT# UNKNOWN, PRODUCT TYPE CATHETER. (B)(4).

    Description of Event or Problem · 1

    GHOSH, D., MAINALI, G., KHERA, J., LUCIANO, M. COMPLICATIONS OF INTRATHECAL BACLOFEN PUMPS IN CHILDREN: EXPERIENCE FROM A TERTIARY CARE CENTER. PEDIATRIC NEUROSURGERY. 2014. SUMMARY: INTRATHECAL BACLOFEN (ITB) THERAPY IS USEFUL IN TREATING SPASTICITY AND DYSTONIA BUT IT HAS MANY COMPLICATIONS, MORE SO IN CHILDREN. THE MAIN AIM OF THE STUDY WAS TO LOOK AT THE COMPLICATIONS OF ITB PUMPS IN CHILDREN WITH THE GOAL OF FUTURE PREVENTION. CHARTS OF ALL PATIENTS= 21 YEARS WITH AN ITB PUMP, IMPLANTED BY A SINGLE PEDIATRIC NEUROSURGEON, AT A SINGLE CENTER, BETWEEN 1996 AND 2011 WERE REVIEWED RETROSPECTIVELY. DATA REGARDING AN ITB TEST TRIAL WERE ALSO RECORDED. DURING 1996¿2011, 119 CHILDREN (MEAN AGE 13.2 YEARS) UNDERWENT ITB PUMP PLACEMENT; 84% HAD SPASTIC QUADRIPLEGIC CEREBRAL PALSY. THE GROSS MOTOR FUNCTION CLASSIFICATION SYSTEM LEVEL WAS = 4 FOR MOST. THE PUMP WAS REMOVED IN 5 (4.2%) PATIENTS DUE TO INEFFICACY. THE MEAN FOLLOW-UP WAS 38 MONTHS. MECHANICAL COMPLICATIONS REQUIRING PUMP AND/OR CATHETER REVISION OCCURRED IN 19.3% AND INFECTIONS IN AN ADDITIONAL 21.8%. SEVEN PATIENTS (6%) HAD MENINGITIS. NO COMPLICATION WAS NOTED AFTER 72 MONTHS OF INITIAL PUMP INSERTION, EVEN AFTER PUMP REINSERTION. THERE IS A NEED FOR BETTER INFECTION CONTROL AS WELL AS BETTER PUMP, CATHETER AND SURGICAL TECHNOLOGY TO LOWER THE COMPLICATIONS OF ITB PUMPS IN CHILDREN. REPORTED EVENTS: (B)(6) IMPROVEMENT WAS NOTED IN ALL EXCEPT 5 CASES WHO LATER DECIDED TO TAKE THE PUMP OUT. EFFICACY HAD DECLINED OVER TIME. (B)(6): 7/35 CASES OF SCOLIOSIS PROGRESSED FURTHER TO REQUIRE CORRECTIVE SCOLIOSIS SURGERY AFTER BACLOFEN PUMP PLACEMENT. (B)(6): THERE WERE 19 INFECTIONS OF THE INCISION SITE. SOME OF THESE PATIENTS WERE PREVIOUSLY REPORTED WITH LIMITED INFORMATION FROM AN OLDER RELATED ARTICLE UNDER MANUFACTURER REPORT # 2 182207-2008-06646 (2008). THE SOURCE OF THE PREVIOUS ARTICLE IS LISTED BELOW. PLEASE DISREGARD THAT REPORT AND CONSIDER THIS THE ACTIVE REPORT. ANY ADDITIONAL INFORMATION RECEIVED WILL BE FILED UNDER THIS REPORT. (B)(6): THERE WERE 3 CASES OF MENINGITIS WITH INFECTION AT THE INCISION SITE. SOME OF THESE PATIENTS WERE PREVIOUSLY REPORTED WITH LIMITED INFORMATION FROM AN OLDER RELATED ARTICLE UNDER MANUFACTURER REPORT # 2 182207-2008-06629 (2008). THE SOURCE OF THE PREVIOUS ARTICLE IS LISTED BELOW. PLEASE DISREGARD THAT REPORT AND CONSIDER THIS THE ACTIVE REPORT. ANY ADDITIONAL INFORMATION RECEIVED WILL BE FILED UNDER THIS REPORT. (B)(6): THERE WERE 10 CASES OF CATHETER DISPLACEMENT/DISCONNECTION. THESE PATIENTS WERE PREVIOUSLY REPORTED WITH LIMITED INFORMATION FROM AN OLDER RELATED ARTICLE UNDER MANUFACTURER REPORT # 2182207-2008-06653 (2008). THE SOURCE OF THE PREVIOUS ARTICLE IS LISTED BELOW. PLEASE DISREGARD THAT REPORT AND CONSIDER THIS THE ACTIVE REPORT. ANY ADDITIONAL INFORMATION RECEIVED WILL BE FILED UNDER THIS REPORT. (B)(6): THERE WERE 8 CASES OF SKIN EROSION OVER THE PUMP. THESE PATIENTS WERE PREVIOUSLY REPORTED WITH LIMITED INFORMATION FROM AN OLDER RELATED ARTICLE UNDER MANUFACTURER REPORT # 2182207-2008-06647 (2008). THE SOURCE OF THE PREVIOUS ARTICLE IS LISTED BELOW. PLEASE DISREGARD THAT REPORT AND CONSIDER THIS THE ACTIVE REPORT. ANY ADDITIONAL INFORMATION RECEIVED WILL BE FILED UNDER THIS REPORT. (B)(6): THERE WERE 4 CASES OF CATHETER FRACTURE. THESE PATIENTS WERE PREVIOUSLY REPORTED WITH LIMITED INFORMATION FROM AN OLDER RELATED ARTICLE UNDER MANUFACTURER REPORT # 2182207-2008-06652 (2008). THE SOURCE OF THE PREVIOUS ARTICLE IS LISTED BELOW. PLEASE DISREGARD THAT REPORT AND CONSIDER THIS THE ACTIVE REPORT. ANY ADDITIONAL INFORMATION RECEIVED WILL BE FILED UNDER THIS REPORT. (B)(6): 1 PATIENT HAD A PERSISTENT CSF LEAK WHICH WAS MANAGED WITH REPAIR OF THE HOLE AROUND THE SPINAL CATHETER ENTRY SITE. THIS PATIENT WAS PREVIOUSLY REPORTED WITH LIMITED INFORMATION FROM AN OLDER RELATED ARTICLE UNDER MANUFACTURER REPORT # 2182207-2008-06649 (2008). THE SOURCE OF THE PREVIOUS ARTICLE IS LISTED BELOW. PLEASE DISREGARD THAT REPORT AND CONSIDER THIS THE ACTIVE REPORT. ANY ADDITIONAL INFORMATION RECEIVED WILL BE FILED UNDER THIS REPORT. PREVIOUS ARTICLE: KHERA J, GHOSH D, LUCIANO M. A STUDY OF INTRATHECAL BACLOFEN PUMPS IN CHILDREN: EXPERIENCE FROM A TERTIARY CARE CENTER. NEUROLOGY. 2008;70 (11, SUPPL.1):A131. TO DETERMINE INDICATIONS, UTILITY, AND COMPLICATIONS OF INTRATHECAL BACLOFEN (ITB) PUMP THERAPY IN CHILDREN. SINGLE CENTER, RETROSPECTIVE REVIEW AFTER IRB APPROVAL. INCLUSION CRITERIA: PATIENTS <(><<)> 21 YEARS WITH ITB PUMP PLACED BETWEEN 1996-2006. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    252804 UNKNOWN_PUMP PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MEDTRONIC NEUROMODULATION UNKNOWN_PUMP

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention