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

Model Number DB-1200-S

Device Problems Delayed Charge Time (2586); Wireless Communication Problem (3283)

Patient Problems Unspecified Infection (1930); Inadequate Pain Relief (2388); No Code Available (3191)

Event Date 09/08/2020

Event Type  Injury  

Event Description

It was reported that the patient was hospitalized for an infection in the scalp.It was later discovered that the patient was also experiencing charging issues and a loss of stimulation.The physician administered antibiotics for the infection.Boston scientific has been unable to obtain additional information regarding the patient outcome to date, despite good faith efforts.

Manufacturer Narrative

B2 outcomes attrib to adv event.B5 describe event or problem.D7 explant date.D10 device avail for evaluation.D10 returned to manufacturer date.H2 if follow-up, what type - additional information.

Event Description

It was reported that the patient was hospitalized for an infection in the scalp.It was later discovered that the patient was also experiencing charging issues and a loss of stimulation.The physician administered antibiotics for the infection.Boston scientific has been unable to obtain additional information regarding the patient outcome to date, despite good faith efforts.Additional information was received that the patient underwent an ipg revision procedure.The patient is doing well post-operatively.

Manufacturer Narrative

H6 3191: no code available was used as there is no equivalent fda code for surgery.H6 evaluation result codes - operational problem identified 114; no device problem found 213.The complaint of infection in the scalp had source of the infection not able to be determined as the device history record review and residual gas analysis found no anomalies.The probable cause has been traced to known inherent risk of device.The complaint of difficulty chagrining the ipg was confirmed through product analysis.Although electrocautery was reported not to have been used, the signatures of the damage suggest that the ipg was exposed to high-voltage transients causing damage to u2 asic resulting in the reported charging issues.The probable cause has been traced to unintended use error caused or contributed to event.

Event Description

It was reported that the patient was hospitalized for an infection in the scalp.It was later discovered that the patient was also experiencing charging issues and a loss of stimulation.The physician administered antibiotics for the infection.Boston scientific has been unable to obtain additional information regarding the patient outcome to date, despite good faith efforts.Additional information was received that the patient underwent an ipg revision procedure.The patient is doing well post-operatively.

• Brand Name: VERCISE GEVIA
• 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: 10623299
• MDR Text Key: 209765738
• Report Number: 3006630150-2020-04598
• Device Sequence Number: 1
• Product Code: NHL
• UDI-Device Identifier: 08714729984443
• UDI-Public: 08714729984443
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup,Followup
• Report Date: 01/07/2021

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?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 03/03/2022
• Device Model Number: DB-1200-S
• Device Catalogue Number: DB-1200-S
• Device Lot Number: 742362
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/25/2020
• Initial Date Manufacturer Received: 09/08/2020
• Initial Date FDA Received: 10/02/2020
• Supplement Dates Manufacturer Received: 11/13/2020; 12/10/2020
• Supplement Dates FDA Received: 12/09/2020; 01/07/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 63 YR