MAUDE Adverse Event Report: BOSTON SCIENTIFIC NEUROMODULATION INFINION 16; STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF

Model Number SC-2316-50E

Device Problems Fracture (1260); Device Dislodged or Dislocated (2923)

Patient Problem Foreign Body In Patient (2687)

Event Date 05/31/2022

Event Type  malfunction  

Manufacturer Narrative

Additional suspect medical device component involved in the event: product family: scs-linear leads.Upn: m365sc231650e0.Model: sc-2316-50e.Serial: (b)(4).Batch: 7157883.

Event Description

It was reported that during a trial procedure, the patients trial lead was fractured.It was also noted that the three contacts broke off and were left inside the patients body.The patient was doing well post-operatively.

Event Description

It was reported that during a trial procedure, the patients trial lead was fractured.It was also noted that the three contacts broke off and were left inside the patients body.The patient was doing well post-operatively.

Manufacturer Narrative

Sc-2316-50e (sn (b)(6)).The returned lead was analyzed and visual inspection revealed that the top three electrodes are separated from the distal end.Electrodes 1-3 were not returned.The cables are exposed at the damaged portion of the lead.With all the available information, boston scientific concludes: the allegation of lead damage was confirmed.This kind of anomaly is consistent with the damages done to a lead when the orientation of the insertion needles bevel is facing down, or the angle of the insertion needle is greater than 45 degrees.The probable cause selected is unintended use error caused or contributed to event.

• Brand Name: INFINION 16
• Type of Device: STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF
• 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; * 00646-2602
• Manufacturer Contact: talar tahmasian ; 25155 rye canyon loop; valencia, CA 91355 ; 6619494863
• MDR Report Key: 14746764
• MDR Text Key: 295441316
• Report Number: 3006630150-2022-02988
• Device Sequence Number: 1
• Product Code: LGW
• UDI-Device Identifier: 08714729797807
• UDI-Public: 08714729797807
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P030017
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 08/10/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/20/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 03/19/2024
• Device Model Number: SC-2316-50E
• Device Catalogue Number: SC-2316-50E
• Device Lot Number: 7157886
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/19/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/21/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 82 YR
• Patient Sex: Male