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 04/07/2020

Event Type  Injury  

Manufacturer Narrative

(b)(4).Additional suspect medical device component involved in the event: product family: dbs-ipg-r-mri, upn: (b)(4), model : db-1200-s, serial : (b)(4), lot: 736836.Product family: dbs-linear leads, upn: (b)(4), model : db-2202-45, serial : (b)(4), lot: 5076598.

Event Description

It was reported that the patient experienced inadequate stimulation due to high impedances on the right dbs lead.The patient was reprogrammed, however, the issue was not resolved.The patient then underwent a procedure to determine the cause of the event.During the procedure, the skull site was first opened and the operating room cable was hooked to the affected lead and determined that the lead was intact.The pocket site was then opened and the lead extension was tested with the or cable and it too was intact.The physician then reseated the lead extension in the ipg header and the event of high impedances was resolved.The surgeon suspected that he may not have tightened the screw in the ipg header block during the initial implant surgery.Post-operatively, all impedances were tested and found to be in normal impedance ranges.

• 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
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; road 698, lot no. 12; dorado PR 00646 -260; RQ 00646-2602
• Manufacturer Contact: talar tahmasian ; 25155 rye canyon loop; valencia, CA 91355 ; 6619494863
• MDR Report Key: 11016293
• MDR Text Key: 221728688
• Report Number: 3006630150-2020-06218
• Device Sequence Number: 1
• Product Code: MHY
• UDI-Device Identifier: 08714729820765
• UDI-Public: 08714729820765
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P150031
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 12/15/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/16/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 09/03/2020
• Device Model Number: NM-3138-55
• Device Catalogue Number: NM-3138-55
• Device Lot Number: 7031617
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/30/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/04/2018
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 68 YR