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Driver Instrument, part of the Superion Indirect… recallZ-1972-2023 · Boston Scientific Neuromodulation Corporation · initiated May 12, 2023

Open, Classified

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Boston Scientific Neuromodulation Corporation or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

Pending update to indirect decompression system instructions for use informing users that excessive force during the implant procedure may cause driver instrument tip breaks, which may result in metal fragments (Driver teeth/tips) within the implant location; and if metal fragments are not removed and remain in situ, MRI scans are NOT advised due to potential risk of patient injury.

FDA root cause category: Labeling design

What the company is doing

On 05/12/23, correction notices were mailed to physicians/surgeons, hospitals, healthcare professionals who were advised the following: IFU advises against forced deployment, as it could result in device breakage. Correction notice advises to review of the IFUs/Surgical Technique Manual. Avoid application of excessive force, use only two or three fingers when performing final tightening during device deployment). Inspect Driver instrument prior to/following use; if Driver tip break is noted: Retrieve metal fragment(s), consider performing imaging. Missing/bent teeth prevents Driver engagement with implant and requires exchange for a new/replacement Driver instrument to complete successful deployment. If metal fragment(s) are not successfully removed: MRI scans are NOT advised, Append the patient s medical record with a copy of this letter to maintain awareness of metal fragment(s) remaining in situ for the remaining service life of the device. Consider alternative imaging for patients with metal fragment(s) remaining in situ, e.g., X-ray/ultrasound/CT scan. Distributors asked to notify all customers that have been shipped/sold affected product. Complete/return acknowledgement form to [email protected] or Fax to: Field Action Center (1-866-213-1806). Driver tip breakage can be identified via an audible click, a loss of tactile resistance during the implant procedure, and/or visual detection following removal of the Driver instrument from the inserter tool and subsequent inspection. Adverse events or quality concerns should be reported to [email protected]. If you have any question, contact Senior Management Quality: at 651-581-0761 or email: [email protected] Firm is updating IFU to advise against MRI scanning for patients with unretrieved metal fragments. A separate letter was sent to health care professions providing them with a patient letter. Patient letter states firm recommends patients discuss this letter with t

Recall details

Recall number
Z-1972-2023
Status
Open, Classified
Initiated by the company
May 12, 2023
Posted by the FDA
Jun 15, 2023
Recalling firm
Boston Scientific Neuromodulation Corporation
Quantity
21,533
Product code
NQO
FDA submissions
P140004
Distribution
US Nationwide Distribution: IN, NY, IL, PA, FL, SC, TX, MA, VA, AL, WI, OK, MO, MI, OH, WV, NC, UT, NH, CA, NJ, TN, NV, AZ, NE, IA, CT, ME, LA, KY, MS, MD, DC, GA, CO, KS, ID, MN, AR, HI, NM, WA, SD, OR, DE, WY, AK, and ND

Product description

Driver Instrument, part of the Superion Indirect Decompression System, REF: 102-9800, used with the Superion Indirect Decompression System IFU, Superion IDS Kit IFU, Surgical Technique Manual

Code information (models, lots, serial numbers)

Driver UDI-DI: 00884662000574, UPN: 102-9800, All Lots. Superion Indirect Decompression System IFU (92479815-02), Superion IDS Kit IFU (92479820-02), Surgical Technique Manual (92479821-02)

Devices named in this recall

1 device in the FDA device registry whose identifier appears in the recall's code information.

Other devices under the same FDA submission

6 devices cleared under P140004 are not named by identifier in this recall. One submission often covers many models, so they may or may not be affected.

Sources and updates

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