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

Model Number NM-3138-55

Device Problems High impedance (1291); Unexpected Therapeutic Results (1631)

Patient Problem No Code Available (3191)

Event Date 06/30/2020

Event Type  Injury  

Manufacturer Narrative

Additional suspect devices: model number: nm-3138-55 dbs-extension, serial numbers: (b)(4).

Event Description

It was reported that the patient did not feel stimulation on one side.One of the patients four lead extensions displayed high impedances on four contacts.The patient underwent a revision procedure and the physician replaced the lead extension.It is not known which one of the four lead extensions was replaced.The patient was doing well following the procedure and is receiving good stimulation.The explanted lead extension will not be returned as it was retained by the hospital.

Event Description

It was reported that the patient did not feel stimulation on one side.One of the patients four lead extensions displayed high impedances on four contacts.The patient underwent a revision procedure and the physician replaced the lead extension.It is not known which one of the four lead extensions was replaced.The patient was doing well following the procedure and is receiving good stimulation.The explanted lead extension will not be returned as it was retained by the hospital.

• Brand Name: NA
• Type of Device: STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR
• Manufacturer (Section D): BOSTON SCIENTIFIC NEUROMODULATION; 25155 rye canyon loop; valencia CA 91355
• MDR Report Key: 10330163
• MDR Text Key: 200608822
• Report Number: 3006630150-2020-03109
• Device Sequence Number: 1
• Product Code: MHY
• UDI-Device Identifier: 08714729820765
• UDI-Public: 08714729820765
• Combination Product (y/n): N
• PMA/PMN Number: P150031
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 08/06/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/27/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 03/17/2020
• Device Model Number: NM-3138-55
• Device Catalogue Number: NM-3138-55
• Device Lot Number: 7013093
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/29/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention