MAUDE Adverse Event Report: BOSTON SCIENTIFIC NEUROMODULATION VERCISE 8 CONTACT EXTENSION KIT; STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR

Model Number NM-3138-55

Device Problems Fracture (1260); High impedance (1291); Unexpected Therapeutic Results (1631)

Patient Problem No Code Available (3191)

Event Date 11/15/2018

Event Type  malfunction  

Manufacturer Narrative

Date of birth: 2003 (exact date is unknown).Additional suspect medical device component involved in the event: model: nm-3138-55, serial: (b)(4), description: vercise 8 contact extension kit.A review of the manufacturing documentation for the lead extensions revealed that no anomalies or deviations potentially related to the event occurred during manufacturing.

Event Description

A report was received that the patient experienced a loss of therapy.It was noted that both of the patients leads exhibited high impedances.An xray confirmed that both lead extension cables are torn out of the connector piece at the head.The physician indicated that he suspects that the patients body movements caused the event by mechanical stress.The physician indicated that the patient will now have to undergo a revision procedure, however a procedure has not been scheduled.

• Brand Name: VERCISE 8 CONTACT EXTENSION KIT
• 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): GUIDANT PUERTO RICO, B.V.; no. 12, road 698; ,; dorado PR 00646 3311
• Manufacturer Contact: talar tahmasian ; 25155 rye canyon loop; ,; valencia, CA 91355 ; 6619494863
• MDR Report Key: 8156916
• MDR Text Key: 130318040
• Report Number: 3006630150-2018-62230
• Device Sequence Number: 1
• Product Code: MHY
• UDI-Device Identifier: 08714729820765
• UDI-Public: 08714729820765
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: P150031
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 12/12/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/12/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 08/02/2019
• Device Model Number: NM-3138-55
• Device Catalogue Number: NM-3138-55
• Device Lot Number: 20935214
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/15/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/02/2017
• 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