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

Model Number DB-2201-30-AC

Device Problem Unexpected Therapeutic Results (1631)

Patient Problem Inadequate Pain Relief (2388)

Event Date 12/15/2022

Event Type  Injury  

Event Description

It was reported that the patient who was implanted with a deep brain stimulation system, was not receiving any therapeutic effect.The patient could not feel any stimulation at all.The patient underwent a revision procedure in which the physician chose to explant the two leads that were in the ventral intermediate nucleus (vim) zone, and implant two new leads in the globus pallidus internus (gpi) zone.After the leads were repositioned and replaced, the patient was doing fine and experienced general improvement of symptoms.The explanted leads will not be returned as they were discarded at the medical facility.

Manufacturer Narrative

Model number either db-2201-30-ac or db-2201-30-dc.Additional suspect medical device components involved in the event: product family dbs-linear leads.Upn m365db220130ac0 or m365db220130dc0.Model db-2201-30-ac or db-2201-30-dc.

• Type of Device: STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR
• Manufacturer (Section D): BOSTON SCIENTIFIC NEUROMODULATION; 25155 rye canyon loop; valencia CA 91355
• Manufacturer Contact: erik sherburne ; 25155 rye canyon loop; valencia, CA 91355 ; 7632920920
• MDR Report Key: 16449224
• MDR Text Key: 310325311
• Report Number: 3006630150-2023-00884
• Device Sequence Number: 1
• Product Code: MHY
• Combination Product (y/n): N
• Reporter Country Code: UP
• 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,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 02/27/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/27/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: DB-2201-30-AC
• Device Catalogue Number: DB-2201-30-AC
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/15/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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 Age: 39 YR
• Patient Sex: Female