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

Model Number DB-4600C

Device Problem Use of Device Problem (1670)

Patient Problem No Code Available (3191)

Event Date 10/11/2019

Event Type  Injury  

Manufacturer Narrative

Additional suspect medical device component involved in the event: brand name: suretek.Upn: (b)(4).Model: db-4600c.Serial: n/a.Batch: 24287871.The explanted device was not returned to bsn as it was discarded by the medical facility.It is indicated that the device will not be returned for evaluation; therefore a failure analysis of the complaint device could not be completed.A review of the manufacturing documentation for the burr hole cover revealed that no anomalies or deviations potentially related to the event occurred during manufacturing.

Event Description

A report was received that the patient underwent a revision procedure.The physician indicated that the gate on the burr hole cover opened which then led to the leads migrating.The burr hole clip and cover on the right side was replaced per the physician preference as he indicated that no malfunction was suspected, and the two leads were repositioned.It is unclear which of the two burr hole clips and covers was explanted.The patient was admitted following the procedure and is doing well post operatively.

Manufacturer Narrative

Additional suspect medical device component involved in the event: brand name: suretek, upn: m365db4600c0, model: db-4600c, serial: n/a, batch: 24287871.Additional suspect medical device component (s) involved in the event: brand name: vercise cartesia, upn: m365db2202450, model: db-2202-45, serial: (b)(4), batch: 5170845 and 5174045.The explanted device was not returned to bsn as it was discarded by the medical facility.It is indicated that the device will not be returned for evaluation; therefore a failure analysis of the complaint device could not be completed.A review of the manufacturing documentation for the burr hole cover revealed that no anomalies or deviations potentially related to the event occurred during manufacturing.

Event Description

A report was received that the patient underwent a revision procedure.The physician indicated that the gate on the burr hole cover opened which then led to the leads migrating.The burr hole clip and cover on the right side was replaced per the physician preference as he indicated that no malfunction was suspected, and the two leads were repositioned.It is unclear which of the two burr hole clips and covers was explanted.The patient was admitted following the procedure and is doing well post operatively.

• Brand Name: SURETEK
• 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: 9455674
• MDR Text Key: 172188705
• Report Number: 3006630150-2019-07291
• Device Sequence Number: 1
• Product Code: MHY
• UDI-Device Identifier: 08714729820802
• UDI-Public: 08714729820802
• 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: 12/12/2019

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: 08/21/2021
• Device Model Number: DB-4600C
• Device Catalogue Number: DB-4600C
• Device Lot Number: 24287863
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 12/11/2019
• Initial Date FDA Received: 12/11/2019
• Supplement Dates Manufacturer Received: 12/11/2019
• Supplement Dates FDA Received: 12/12/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 66 YR