MAUDE Adverse Event Report: BOSTON SCIENTIFIC NEUROMODULATION PRECISION SPECTRA; SPINAL CORD STIMULATOR

Model Number SC-2316-50E

Device Problems Break (1069); Material Discolored (1170); Fracture (1260); Material Frayed (1262); Material Separation (1562)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 12/01/2017

Event Type  Injury  

Event Description

A report was received that during the patients lead pull, the trial lead broke off and six contacts were left inside the body.The patient underwent a procedure wherein the said contacts were removed.

Manufacturer Narrative

Sc-2316-50e(b)(4): device evaluation indicated that the visual inspection revealed that the top six electrodes were separated from the distal end.Only electrodes 1-6 were returned, the rest of the lead was not returned.Visual inspection of the fractured cables revealed fraying of the breaks, lack of necking and discoloration associated with welding, and the proximity of the break points to the edge of the insulation indicate that the cables didn't break at or near the welds.The breaks cannot be attributed to the quality of the welding.Available evidence indicates that the lead was subject to an excessive tensile load when resistance was felt during the lead pull.Device history record did not find any anomalies or deviations that potentially relate to the reported event; there was no reason to suspect a manufacturing defect as the source of the reported complaint.

Event Description

A report was received that during the patients lead pull, the trial lead broke off and six contacts were left inside the body.The patient underwent a procedure wherein the said contacts were removed.

Manufacturer Narrative

Additional information was received that the patient underwent a procedure wherein the remaining part of the lead was explanted.

Event Description

A report was received that during the patients lead pull, the trial lead broke off and six contacts were left inside the body.The patient underwent a procedure wherein the said contacts were removed.

• Brand Name: PRECISION SPECTRA
• Type of Device: SPINAL CORD STIMULATOR
• Manufacturer (Section D): BOSTON SCIENTIFIC NEUROMODULATION; 25155 rye canyon loop; valencia CA 91355
• Manufacturer (Section G): BOSTON SCIENTIFIC NEUROMODULATION; 25155 rye canyon loop; valencia CA 91355
• Manufacturer Contact: talar tahmasian ; 25155 rye canyon loop; valencia, CA 91355 ; 6619494863
• MDR Report Key: 7144513
• MDR Text Key: 95718894
• Report Number: 3006630150-2017-05180
• 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: 030017
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 01/24/2018

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: 10/31/2019
• Device Model Number: SC-2316-50E
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/02/2018
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/04/2017
• Initial Date FDA Received: 12/22/2017
• Supplement Dates Manufacturer Received: 12/11/2017; 01/19/2018
• Supplement Dates FDA Received: 12/29/2017; 01/24/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/03/2017
• 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: 41 YR