MAUDE Adverse Event Report: BOSTON SCIENTIFIC NEUROMODULATION VERCISE PC; STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR

Model Number DB-1140

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

Patient Problems Hypersensitivity/Allergic reaction (1907); Unspecified Infection (1930); Pocket Erosion (2013); Implant Pain (4561)

Event Date 12/01/2021

Event Type  Injury  

Event Description

It was reported that the patient experienced an allergic reaction in the pocket area where the deep brain stimulator implantable pulse generator is located.The patient underwent a procedure in which the physician washed and cleaned the pocket site and re-implanted the same device in the same area.At a later date the patient underwent a second washing of the pocket site, and the pocket site was changed to the left side.The physician assessed that the device or procedure did not cause or contribute to the allergic reaction.The patient is well, and the inflammation has decreased.

Event Description

It was reported that the patient experienced an allergic reaction in the pocket area where the deep brain stimulator implantable pulse generator is located.The patient underwent a procedure in which the physician washed and cleaned the pocket site and re-implanted the same device in the same area.At a later date the patient underwent a second washing of the pocket site, and the pocket site was changed to the left side.The physician assessed that the device or procedure did not cause or contribute to the allergic reaction.The patient is well, and the inflammation has decreased.Additional information was received that the second pocket washing was performed because the allergic reaction was not resolved after the first wash.

Manufacturer Narrative

Additional suspect medical device components involved in the event.Product family dbs-extension: upn: m365nm3138550; model:nm-3138-55; serial/lot: (b)(6); batch: 7084056.Product family dbs-extension: upn: m365nm3138550; model: nm-3138-55; serial/lot; (b)(6); batch: 7084027.

Event Description

It was reported that the patient experienced an allergic reaction in the pocket area where the deep brain stimulator implantable pulse generator, ipg is located.The patient underwent a procedure in which the physician washed and cleaned the pocket site and re-implanted the same device in the same area.At a later date the patient underwent a second washing of the pocket site, and the pocket site was changed to the left side.The physician assessed that the device or procedure did not cause or contribute to the allergic reaction.The patient is well, and the inflammation has decreased.Additional information was received that the second pocket washing was performed because the allergic reaction was not resolved after the first wash.Additional information was received that the ipg became exposed at the pocket site and therefore the patient underwent an explant of the ipg and lead extensions.The physician assessed that the patient could have an infection, however this has not been corroborated with the culture results taken.The physician took a new culture during the removal of the device, however the results are unknown.Therefore the physicians strongest hypothesis is that the patient's body rejected the device due to an allergic reaction.The patient was doing well post-operatively.The explanted ipg will be returned.The two explanted lead extensions were discarded at the medical facility.

Manufacturer Narrative

Additional suspect medical device components involved in the event product family dbs-extension.Upn m365nm3138550.Model nm-3138-55.Serial/lot (b)(6).Batch 7084056.Product family dbs-extension, upn m365nm3138550, model nm-3138-55, serial/lot (b)(6), batch 7084027.

Event Description

It was reported that the patient experienced an allergic reaction in the pocket area where the deep brain stimulator implantable pulse generator, ipg is located.The patient underwent a procedure in which the physician washed and cleaned the pocket site and re-implanted the same device in the same area.At a later date the patient underwent a second washing of the pocket site, and the pocket site was changed to the left side.The physician assessed that the device or procedure did not cause or contribute to the allergic reaction.The patient is well, and the inflammation has decreased.Additional information was received that the second pocket washing was performed because the allergic reaction was not resolved after the first wash.Additional information was received that the ipg became exposed at the pocket site and therefore the patient underwent an explant of the ipg and lead extensions.The physician assessed that the patient could have an infection, however this has not been corroborated with the culture results taken.The physician took a new culture during the removal of the device, however the results are unknown.Therefore the physicians strongest hypothesis is that the patient's body rejected the device due to an allergic reaction.The patient was doing well post-operatively.The explanted ipg will be returned.The two explanted lead extensions were discarded at the medical facility.Additional information was received that the culture results were negative for infection.

Event Description

It was reported that the patient experienced an allergic reaction in the pocket area where the deep brain stimulator implantable pulse generator, ipg is located.The patient underwent a procedure in which the physician washed and cleaned the pocket site and re-implanted the same device in the same area.At a later date the patient underwent a second washing of the pocket site, and the pocket site was changed to the left side.The physician assessed that the device or procedure did not cause or contribute to the allergic reaction.The patient is well, and the inflammation has decreased.Additional information was received that the second pocket washing was performed because the allergic reaction was not resolved after the first wash.Additional information was received that the ipg became exposed at the pocket site and therefore the patient underwent an explant of the ipg and lead extensions.The physician assessed that the patient could have an infection, however this has not been corroborated with the culture results taken.The physician took a new culture during the removal of the device, however the results are unknown.Therefore the physicians strongest hypothesis is that the patients body rejected the device due to an allergic reaction.The patient was doing well post-operatively.The explanted ipg will be returned.The two explanted lead extensions were discarded at the medical facility.Additional information was received that the culture results were negative for infection.

Manufacturer Narrative

Additional suspect medical device components involved in the event product family dbs-extension, upn m365nm3138550, model nm-3138-55, serial/lot (b)(6), batch (b)(6).Product family dbs-extension, upn m365nm3138550, model nm-3138-55, serial/lot (b)(6), batch (b)(6).The returned ipg db-1140, sn (b)(6) passed the visual inspection and the residual gas analysis.The two lead extensions (b)(6) were not returned for analysis as they were discarded by the medical facility, therefore, a physical analysis has not been conducted in our laboratory.A review of the manufacturing documentation for the three devices revealed that no anomalies or deviations related to the event occurred during manufacturing.However, a labelling review found that the reported event is a known risk with the use of deep brain stimulation.

Event Description

It was reported that the patient experienced an allergic reaction in the pocket area where the deep brain stimulator implantable pulse generator, ipg is located.The patient underwent a procedure in which the physician washed and cleaned the pocket site and re-implanted the same device in the same area.At a later date the patient underwent a second washing of the pocket site, and the pocket site was changed to the left side.The physician assessed that the device or procedure did not cause or contribute to the allergic reaction.The patient is well, and the inflammation has decreased.Additional information was received that the second pocket washing was performed because the allergic reaction was not resolved after the first wash.Additional information was received that the ipg became exposed at the pocket site and therefore the patient underwent an explant of the ipg and lead extensions.The physician assessed that the patient could have an infection, however this has not been corroborated with the culture results taken.The physician took a new culture during the removal of the device, however the results are unknown.Therefore, the physicians strongest hypothesis is that the patients body rejected the device due to an allergic reaction.The patient was doing well post-operatively.The explanted ipg will be returned.The two explanted lead extensions were discarded at the medical facility.Additional information was received that the culture results were negative for infection.Additional information was received that the patient underwent an allergy test with a patch of unknown materials.The patient did not tolerate the patch, therefore the test was declared to be inconclusive.Due to the intolerance of the patch, the decision was handed over to the treating physician to seek other therapeutic alternatives for the patient.The patient underwent an explant of the remaining two leads and two suretek burr hole cover on (b)(6) 2023.

Manufacturer Narrative

Block d6a explant date of ipg and lead extensions was (b)(6) 2022.Explant date of leads and lead extensions (b)(6) 2023.Additional suspect medical device components involved in the event.Product family dbs-extension; upn m365nm3138550; model nm-3138-55; serial/lot (b)(6).Product family dbs-linear leads; upn m365db2202450; model db-2202-45; serial/lot/batch (b)(6).Product family dbs-lead fixation; upn db4600c0; model db-4600c; serial/lot/batch (b)(6).

Event Description

It was reported that the patient experienced an allergic reaction in the pocket area where the deep brain stimulator implantable pulse generator, ipg is located.The patient underwent a procedure in which the physician washed and cleaned the pocket site and re-implanted the same device in the same area.At a later date the patient underwent a second washing of the pocket site, and the pocket site was changed to the left side.The physician assessed that the device or procedure did not cause or contribute to the allergic reaction.The patient is well, and the inflammation has decreased.Additional information was received that the second pocket washing was performed because the allergic reaction was not resolved after the first wash.Additional information was received that the ipg became exposed at the pocket site and therefore the patient underwent an explant of the ipg and lead extensions.The physician assessed that the patient could have an infection, however this has not been corroborated with the culture results taken.The physician took a new culture during the removal of the device, however the results are unknown.Therefore the physicians strongest hypothesis is that the patient's body rejected the device due to an allergic reaction.The patient was doing well post-operatively.The explanted ipg will be returned.The two explanted lead extensions were discarded at the medical facility.Additional information was received that the culture results were negative for infection.Additional information was received that the patient underwent an allergy test with a patch of unknown materials.The patient did not tolerate the patch, therefore the test was declared to be inconclusive.Due to the intolerance of the patch, the decision was handed over to the treating physician to seek other therapeutic alternatives for the patient.The patient underwent an explant of the remaining two leads and two suretek burr hole cover on (b)(6) 2023.Additional information was received that prior to the lead and burr hole explant of (b)(6) 2023, the patient was experiencing pain in the area where he had the remaining leads.After the explant the patient had improvements in the skin, and no longer experienced allergic reactions.The explanted leads and burr hole will not be returned as they were retained by the medical clinic.

Manufacturer Narrative

Additional suspect medical device components involved in the event: product family dbs-extension: upn m365nm3138550.Model nm-3138-55.Serial/lot (b)(6).Product family dbs-linear leads: upn m365db2202450.Model db-2202-45.Serial/lot/batch (b)(6).Product family dbs-lead fixation: upn db4600c0.Model db-4600c.Serial/lot/batch (b)(6).

• Brand Name: VERCISE PC
• Type of Device: STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR
• Manufacturer (Section D): BOSTON SCIENTIFIC NEUROMODULATION; 25155 rye canyon loop; valencia CA 91355
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; cashel road; clonmel ; EI
• Manufacturer Contact: erik sherburne ; 25155 rye canyon loop; valencia, CA 91355 ; 7632920920
• MDR Report Key: 14198005
• MDR Text Key: 290069872
• Report Number: 3006630150-2022-01826
• Device Sequence Number: 1
• Product Code: MHY
• Combination Product (y/n): N
• Reporter Country Code: CO
• PMA/PMN Number: P150031
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 06/16/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/25/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 03/24/2023
• Device Model Number: DB-1140
• Device Catalogue Number: DB-1140
• Device Lot Number: 633418
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/25/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/24/2021
• 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): Required Intervention
• Patient Sex: Male