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

Model Number NM-3138-55

Device Problems Fracture (1260); High impedance (1291)

Patient Problems Dyskinesia (2363); No Code Available (3191)

Event Date 11/24/2020

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that impedances were out of range.The patient underwent a surgical procedure where it was discovered that the extension was damaged and almost severed.The extension was replaced and impedance issue was resolved.The patient was well post operatively.It was noted that the patient suffers from tardive dyskinesia and the physician assessed that the damage was likely caused by the extension junction being pulled against the wall or floor while the patient was experiencing dyskinesias.

Manufacturer Narrative

With all the available information boston scientific concludes the reported event was confirmed.Visual inspection revealed that the connector/distal end of the lead extension were separated from the lead body.Xray inspection of the lead extension revealed all cables were fractured after the weld in the distal connector stack.It appears that excessive tensile force was exerted onto the lead body and connector and it resulted in the lead extension damage.The complaint of high impedances was confirmed through product analysis.The probable cause has been traced to component failure.

Event Description

It was reported that impedances were out of range.The patient underwent a surgical procedure where it was discovered that the extension was damaged and almost severed.The extension was replaced and impedance issue was resolved.The patient was well post operatively.It was noted that the patient suffers from tardive dyskinesia and the physician assessed that the damage was likely caused by the extension junction being pulled against the wall or floor while the patient was experiencing dyskinesias.

• 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: 11120231
• MDR Text Key: 225252667
• Report Number: 3006630150-2020-06573
• 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,health
• Type of Report: Initial,Followup
• Report Date: 02/18/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 06/24/2022
• Device Model Number: NM-3138-55
• Device Catalogue Number: NM-3138-55
• Device Lot Number: 7076773
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/23/2020
• Initial Date Manufacturer Received: 12/08/2020
• Initial Date FDA Received: 01/05/2021
• Supplement Dates Manufacturer Received: 01/28/2021
• Supplement Dates FDA Received: 02/18/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 30 YR