MAUDE Adverse Event Report: MEDTRONIC NEUROMODULATION UNKNOWN IMPLANTABLE NEUROSTIMULATOR; STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR

Model Number NEU_INS_STIMULATOR

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Wound Dehiscence (1154); Abscess (1690); Bacterial Infection (1735); Purulent Discharge (1812); Unspecified Infection (1930); Pocket Erosion (2013); Staphylococcus Aureus (2058)

Event Date 02/11/2019

Event Type  Injury  

Manufacturer Narrative

Please note that this age is the average age of the parkinson's disease patients reported in the article; please note that this is the gender of the majority of parkinson's disease patients reported in the article ; please note that this date is based off the date of publication of the article as the actual event date was not provided.Other relevant device(s) are: product id: neu_unknown_lead, serial/lot #: unknown; product id: neu_unknown_ext, serial/lot #: unknown; product id: neu_ins_stimulator, serial/lot #: unknown.The reported events were from the following literature article: levi v, messina g, franzini a, di laurenzio ne, franzini a, tringali g, rizzi m.Antibiotics impregnated catheter coating technique for deep brain stimulation hardware infection: an effective method to avoid intracranial lead removal.Operative neurosurgery 0:1-8(2019).Doi: 10.1093/ons.Opz118.If information is provided in the future, a supplemental report will be issued.

Event Description

The following events were reported in literature: one (b)(6) year-old male patient with bilateral subthalamic nucleus (stn) deep brain stimulation (dbs) for parkinson¿s disease (pd) experienced a type ii infection of the right implantable neurostimulator (ins) 180 days after ins replacement.It was unclear if there was skin erosion and subcutaneous tissue involvement.After performing a brain computed tomography with contrast enhancement to rule out brain or meninges involvement, a superficial swab was obtained, and the patient was immediately started on ceftriaxone 2g iv q 12h and vancomycin 15 mg/kg q 12h for two weeks.Antibiotic treatment was then modified according to the results of the microbiological culture.Microbial cultures were negative.Due to the non-response to antibiotic therapy, incision, drainage, and hardware exploration was performed.The right ins and cable were removed 15 days later, with an attempt to spare the intracranial lead.The distal end of the lead was enveloped with a short segment (approximately 4cm long) of antibiotic-impregnated ventricular catheter containing clindamycin and rifampin.Sutures were used to close off the proximal end of the catheter in order to anchor it to the lead.After hardware removal, antibiotic treatment was continued intravenously for another two weeks.At the six-month follow-up, the patient underwent successful reimplantation of the extension and ins, which were connected to the salvaged lead.No further infective or hardware-related complications were noticed during the long-term follow-up.One (b)(6) year-old male patient with bilateral subthalamic nucleus (stn) deep brain stimulation (dbs) for parkinson¿s disease (pd) experienced a type ii infection of the left lead-cable junction 180 days after implantable neurostimulator (ins) replacement.After performing a brain computed tomography with contrast enhancement to rule out brain or meninges involvement, a superficial swab was obtained, and the patient was immediately started on ceftriaxone 2g iv q 12h and vancomycin 15 mg/kg q 12h for two weeks.Antibiotic treatment was then modified according to the results of the microbiological culture.Microbial cultures found coagulase-negative staphylococci (cons).Due to the non-response to antibiotic therapy, incision, drainage, and hardware exploration was performed.The left ins and cable were removed 16 days later, with an attempt to spare the intracranial lead.The distal end of the lead was enveloped with a short segment (approximately 4cm long) of antibiotic-impregnated ventricular catheter containing clindamycin and rifampin.Sutures were used to close off the proximal end of the catheter in order to anchor it to the lead.After hardware removal, antibiotic treatment was continued intravenously for another two weeks.At the six-month follow-up, the patient underwent successful reimplant ation of the extension and ins, which were connected to the salvaged lead.No further infective or hardware-related complications were noticed during the long-term follow-up.One (b)(6) year-old male patient with bilateral subthalamic nucleus (stn) deep brain stimulation (dbs) for parkinson¿s disease (pd) experienced a type ii infection of the right lead-cable unction 210 days after ins replacement.After performing a brain computed tomography with contrast enhancement to rule out brain or meninges involvement, a superficial swab was obtained, and the patient was immediately started on ceftriaxone 2g iv q 12h and vancomycin 15 mg/kg q 12h for two weeks.Antibiotic treatment was then modified according to the results of the microbiological culture.Microbial cultures were negative.Due to the non-response to antibiotic therapy, incision, drainage, and hardware exploration was performed.The right ins and cable were removed 15 days later, with an attempt to spare the intracranial lead.The distal end of the lead was enveloped with a short segment (approximately 4cm long) of antibiotic-impregnated ventricular catheter containing clindamycin and rifampin.Sutures were used to close off the proximal end of the cathete r in order to anchor it to the lead.After hardware removal, antibiotic treatment was continued intravenously for another two weeks.A dehiscence of the antibiotic catheter was noticed after two months; therefore, all hardware was removed.It was noted that this was initially conservatively managed by the patient¿s general practitioner with two weeks of oral antibiotics.One (b)(6) year-old female patient with bilateral subthalamic nucleus (stn) deep brain stimulation (dbs) for parkinson¿s disease (pd) experienced a type ii infection of the left implantable neurostimulator (ins) 240 days after lead placement.After performing a brain computed tomography with contrast enhancement to rule out brain or meninges involvement, a superficial swab was obtained, and the patient was immediately started on ceftriaxone 2g iv q 12h and vancomycin 15 mg/kg q 12h for two weeks.Antibiotic treatment was then modified according to the results of the microbiological culture.Microbial cultures showed (b)(6).Due to the non-response to antibiotic therapy, incision, drainage, and hardware exploration was performed.The left ins and cable were removed 17 days later, with an attempt to spare the intracranial lead.The distal end of the lead was enveloped with a short segment (approximately 4cm long) of antibiotic-impregnated ventricular catheter containing clindamycin and rifampin.Sutures were used to close off the proximal end of the catheter in order to anchor it to the lead.After hardware removal, antibiotic treatment was continued intravenously for another two weeks.At the six-month follow-up, the patient underwent successful reimplant ation of the extension and ins, which were connected to the salvaged lead.No further infective or hardware-related complications were noticed during the long-term follow-up.One (b)(6) year-old male patient with bilateral subthalamic nucleus (stn) deep brain stimulation (dbs) for parkinson¿s disease (pd) experienced a type ii infection of the right lead-cable junction 210 days after lead placement.After performing a brain computed tomography with contrast enhancement to rule out brain or meninges involvement, a superficial swab was obtained, and the patient was immediately started on ceftriaxone 2g iv q 12h and vancomycin 15 mg/kg q 12h for two weeks.Antibiotic treatment was then modified according to the results of the microbiological culture.Microbial cultures were negative.Due to the non-response to antibiotic therapy, incision, drainage, and hardware exploration was performed.The right implantable neurostimulator (ins) and cable were removed 15 days later, with an attempt to spare the intracranial lead.The distal end of the lead was enveloped with a short segment (approximately 4cm long) of antibiotic-impregnated ventricular catheter containing clindamycin and rifampin.Sutures were used to close off the proximal end of the catheter in order to anchor it to the lead.After hardware removal, antibiotic treatment was continued intravenously for another two weeks.At the six-month follow-up, the patient underwent successful reimplantation of the extension and ins, which were connected to the salvaged lead.No further infective or hardware-related complications were noticed during the long-term follow-up.One (b)(6) year-old female patient with bilateral subthalamic nucleus (stn) deep brain stimulation (dbs) for parkinson¿s disease (pd) experienced a type ii infection of the right lead-cable junction 150 days after lead placement.After performing a brain computed tomography with contrast enhancement to rule out brain or meninges involvement, a superficial swab was obtained, and the patient was immediately started on ceftriaxone 2g iv q 12h and vancomycin 15 mg/kg q 12h for two weeks.Antibiotic treatment was then modified according to the results of the microbiological culture.Microbial cultures showed (b)(6).Due to the non-response to antibiotic therapy, incision, drainage, and hardware exploration was performed.The right implantable neurostimulator (ins) and cable were removed 15 days later, with an attempt to spare the intracranial lead.The distal end of the lead was enveloped with a short segment (approximately 4cm long) of antibiotic-impregnated ventricular catheter containing clindamycin and rifampin.Sutures were used to close off the proximal end of the catheter in order to anchor it to the lead.After hardware removal, antibiotic treatment was continued intravenously for another two weeks.At the six-month follow-up, the patient underwent successful reimplantation of the extension and ins, which were connected to the salvaged lead.No further infective or hardware-related complications were noticed during the long-term follow-up.One (b)(6) year-old female patient with bilateral subthalamic nucleus (stn) deep brain stimulation (dbs) for parkinson¿s disease (pd) experienced a type ii infection of the right lead-cable junction 120 days after lead placement.After performing a brain computed tomography with contrast enhancement to rule out brain or meninges involvement, a superficial swab was obtained, and the patient was immediately started on ceftriaxone 2g iv q 12h and vancomycin 15 mg/kg q 12h for two weeks.Antibiotic treatment was then modified according to the results of the microbiological culture.Microbial cultures were negative.Due to the non-response to antibiotic therapy, incision, drainage, and hardware exploration was performed.The right implantable neurostimulator (ins) and cable were removed 16 days later, with an attempt to spare the intracranial lead.It was unclear if purulent drainage was present in this case; however, in cases of purulent drainage, the leads were disconnected, and the extensions and ins were discarded, while lead extra-cranial contacts were covered with a protective cap and buried in a subcutaneous parietal pocket distant from the site of infection.After hardware removal, antibiotic treatment was continued intravenously for another two weeks.However, the patient presented clinical and radiological signs of persistent infection, which led to the complete hardware removal.One (b)(6) year-old male patient with bilateral subthalamic nucleus (stn) deep brain stimulation (dbs) for parkinson¿s disease (pd) experienced a type ii infection of the right lead-cable junction 365 days after lead placement.After performing a brain computed tomography with contrast enhancement to rule out brain or meninges involvement, a superficial swab was obtained, and the patient was immediately started on ceftriaxone 2g iv q 12h and vancomycin 15 mg/kg q 12h for two weeks.Antibiotic treatment was then modified according to the results of the microbiological culture.Microbial cultures found (b)(6).Due to the non-response to antibiotic therapy, incision, drainage, and hardware exploration was performed.The right implantable neurostimulator (ins) and cable were removed 15 days later, with an attempt to spare the intracranial lead.It was unclear if purulent drainage was present in this case; however, in cases of purulent drainage, the leads were disconnected, and the extensions and ins were discarded, while lead extra-cranial contacts were covered with a protective cap and buried in a subcutaneous parietal pocket distant from the site of infection.After hardware removal, antibiotic treatment was continued intravenously for another two weeks.However, the patient presented clinical and radiological signs of persistent infection, which led to the complete hardware removal.One (b)(6) year-old male patient with bilateral subthalamic nucleus (stn) deep brain stimulation (dbs) for parkinson¿s disease (pd) experienced a type ii infection of the right implantable neurostimulator (ins) 210 days after ins replacement.After performing a brain computed tomography with contrast enhancement to rule out brain or meninges involvement, a superficial swab was obtained, and the patient was immediately started on ceftriaxone 2g iv q 12h and vancomycin 15 mg/kg q 12h for two weeks.Antibiotic treatment was then modified according to the results of the microbiological culture.Microbial cultures were negative.Due to the non-response to antibiotic therapy, incision, drainage, and hardware exploration was performed.The right ins and cable were removed 15 days later, with an attempt to spare the intracranial lead.It was unclear if purulent drainage was present in this case; however, in cases of pur ulent drainage, the leads were disconnected, and the extensions and ins were discarded, while lead extra-cranial contacts were covered with a protective cap and buried in a subcutaneous parietal pocket distant from the site of infection.After hardware removal, an tibiotic treatment was continued intravenously for another two weeks.However, the patient presented clinical and radiological signs of persistent infection, which led to the complete hardware removal.One (b)(6) year-old male patient with bilateral subthalamic nucleus (stn) deep brain stimulation (dbs) for parkinson¿s disease (pd) experienced a type ii infection of the right implantable neurostimulator (ins) 90 days after ins replacement.After performing a brain computed tomography with contrast enhancement to rule out brain or meninges involvement, a superficial swab was obtained, and the patient was immediately started on ceftriaxone 2g iv q 12h and vancomycin 15 mg/kg q 12h for two weeks.Antibiotic treatment was then modified according to the results of the microbiological culture.Microbial cultures were negative.Due to the non-response to antibiotic therapy, incision, drainage, and hardware exploration was performed.The right ins and cable were removed 15 days later, with an attempt to spare the intracranial lead.It was unclear if purulent drainage was present in this case; however, in cases of purulent drainage, the leads were disconnected, and the extensions and ins were discarded, while lead extra-cranial contacts were covered with a protective cap and buried in a subcutaneous parietal pocket distant from the site of infection.After hardware removal, antibiotic treatment was continued intravenously for another two weeks.However, the patient presented clinical and radiological signs of persistent infection, which led to the complete hardware removal.One (b)(6) year-old female patient with bilateral subthalamic nucleus (stn) deep brain stimulation (dbs) for parkinson¿s disease (pd) experienced a type ii infection of the right lead-cable junction 180 days after lead placement.After performing a brain computed tomography with contrast enhancement to rule out brain or meninges involvement, a superficial swab was obtained, and the patient was immediately started on ceftriaxone 2g iv q 12h and vancomycin 15 mg/kg q 12h for two weeks.Antibiotic treatment was then modified according to the results of the microbiological culture.Microbial cultures showed (b)(6).Due to the non-response to antibiotic therapy, incision, drainage, and hardware exploration was performed.The right ins and cable were removed 15 days later, with an attempt to spare the intracranial lead.It was unclear if purulent drainage was present in this case; however, in cases of purulent drainage, the leads were disconnected, and the extensions and ins were discarded, while lead extra-cranial contacts were covered with a protective cap and buried in a subcutaneous parietal pocket distant from the site of infection.After hardware removal, antibiotic treatment was continued intravenously for another two weeks.However, the patient presented clinical and radiological signs of persistent infection, which led to the complete hardware removal.One (b)(6) year-old female patient with bilateral subthalamic nucleus (stn) deep brain stimulation (dbs) for parkinson¿s disease (pd) experienced a type ii infection of the right lead-cable junction 210 days after implantable neurostimulator (ins) replacement.After performing a brain computed tomography with contrast enhancement to rule out brain or meninges involvement, a superficial swab was obtained, and the patient was immediately started on ceftriaxone 2g iv q 12h and vancomycin 15 mg/kg q 12h for two weeks.Antibiotic treatment was then modified according to the results of the microbiological culture.Microbial cultures were negative.Due to the non-response to antibiotic therapy, incision, drainage, and hardware exploration was performed.The right ins and cable were removed 16 days later, with an attempt to spare the intracranial lead.It was unclear if purulent drainage was present in this case; however, in cases of purulent drainage, the leads were disconnected, and the extensions and ins were discarded, while lead extra-cranial contacts were covered with a protective cap and buried in a subcutaneous parietal pocket distant from the site of infection.After hardware removal, antibiotic treatment was continued intravenously for another two weeks.However, the patient presented clinical and radiological signs of persistent infection, which led to the complete hardware removal.One (b)(6) year-old male patient with bilateral subthalamic nucleus (stn) deep brain stimulation (dbs) for parkinson¿s disease (pd) experienced a type i infection of the left implantable neurostimulator (ins) 21 days after lead placement.Microbial culture found (b)(6).The patient was treated with ceftriaxone 2gm iv q12 hrs and vancomycin 15mg/kg q 12 hrs for 14 days.No revision was needed, and the infection resolved.One (b)(6) year-old male patient with bilateral subthalamic nucleus (stn) deep brain stimulation (dbs) for parkinson¿s disease (pd) experienced a type iii infection of the right lead-cable junction 150 days after lead placement.Type iii infection was determined using radiological evidence of brain parenchyma infection/brain abscess.Microbial cultures were negative.The right implantable neurostimulator (ins), cable, and lead (entire dbs system) were urgently removed 1 day later.After hardware removal, antibiotic treatment was continued intravenously for at least another two weeks (prolonged antibiotics therapy).The following device specifics were reported: activa pc implantable neurostimulator; activa sc implantable neurostimulator; soletra implantable neurostimulator.

• Brand Name: UNKNOWN IMPLANTABLE NEUROSTIMULATOR
• Type of Device: STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR
• 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: 8756193
• MDR Text Key: 150253131
• Report Number: 3007566237-2019-01473
• Device Sequence Number: 1
• Product Code: MHY
• Combination Product (y/n): N
• Reporter Country Code: IT
• PMA/PMN Number: P960009
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,l
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 07/02/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/02/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: NEU_INS_STIMULATOR
• Device Catalogue Number: NEU_INS_STIMULATOR
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/04/2019
• 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): Other; Required Intervention
• Patient Age: 46 YR