MAUDE Adverse Event Report: BOSTON SCIENTIFIC NEUROMODULATION VERCISE PC; STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN SYMPTOMS

Model Number DB-1140-S

Device Problems Unexpected Therapeutic Results (1631); Low impedance (2285); Device Displays Incorrect Message (2591)

Patient Problem No Code Available (3191)

Event Date 07/07/2020

Event Type  Injury  

Event Description

It was reported that during a revision procedure, the ipg stopped functioning and had to be replaced.Once the ipg was replaced, the patient was fine.

Manufacturer Narrative

Additional information: d10.It was reported that during a revision procedure, the ipg stopped functioning.The complaint was confirmed.Device communication could not be established due to asic u1 and battery damage.Exposing the ipg electronics to high voltage transients could cause the electrical short within the asic u1.Representative verified that patients ipg was turned off before surgery and that grounding pad was away from ipg.However, based on the signature of the damage, ipg was most likely exposed to electrocautery during the operation.The probable cause selected is unintended use error caused or contributed to event.

Event Description

It was reported that during a revision procedure, the ipg stopped functioning and had to be replaced.Once the ipg was replaced, the patient was fine.

• Brand Name: VERCISE PC
• Type of Device: STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN SYMPTOMS
• Manufacturer (Section D): BOSTON SCIENTIFIC NEUROMODULATION; 25155 rye canyon loop; valencia CA 91355
• MDR Report Key: 10347944
• MDR Text Key: 201349893
• Report Number: 3006630150-2020-03179
• Device Sequence Number: 1
• Product Code: NHL
• UDI-Device Identifier: 08714729984467
• UDI-Public: 08714729984467
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Type of Report: Initial,Followup
• Report Date: 09/28/2020

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: 02/11/2021
• Device Model Number: DB-1140-S
• Device Catalogue Number: DB-1140-S
• Device Lot Number: 631464
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/10/2020
• Initial Date Manufacturer Received: 07/07/2020
• Initial Date FDA Received: 07/30/2020
• Supplement Dates Manufacturer Received: 09/02/2020
• Supplement Dates FDA Received: 09/28/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other