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

Model Number SC-8216-70

Device Problems High impedance (1291); Material Separation (1562)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 08/09/2017

Event Type  malfunction  

Event Description

A report was received that during implant procedure, the physician noticed a visible defect in the lead wherein the contacts were popping out.The patient underwent a revision procedure wherein the lead was replaced.Device malfunction was suspected.

Manufacturer Narrative

Sc-8216-70, sn (b)(4): device evaluation indicate visual inspection revealed traces of dry blood at the paddle, this suggest that paddle lead was implanted/explanted.Additionally the electrodes # 6 & 14 are partially dislodged from paddle.Device history record did not find any anomalies or deviations that potentially relate to the reported event; there is no reason to suspect a manufacturing defect as the source of the reported complaint.

Event Description

A report was received that during implant procedure, the physician noticed a visible defect in the lead wherein the contacts were popping out.The patient underwent a revision procedure wherein the lead was replaced.Device malfunction was suspected.

Event Description

A report was received that during implant procedure, the physician noticed a visible defect in the lead wherein the contacts were popping out.The patient underwent a revision procedure wherein the lead was replaced.Device malfunction was suspected.

Manufacturer Narrative

Additional information was received that before inserting the lead into the patient, the surgeon noticed that the contacts looked funny so he asked for a different paddle.

Event Description

A report was received that during implant procedure, the physician noticed a visible defect in the lead wherein the contacts were popping out.The patient underwent a revision procedure wherein the lead was replaced.Device malfunction was suspected.

• 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: 6822206
• MDR Text Key: 83699303
• Report Number: 3006630150-2017-03243
• Device Sequence Number: 1
• Product Code: LGW
• Combination Product (y/n): N
• 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,Followup
• Report Date: 12/07/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 07/25/2019
• Device Model Number: SC-8216-70
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/06/2017
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/09/2017
• Initial Date FDA Received: 08/25/2017
• Supplement Dates Manufacturer Received: 08/09/2017; 08/09/2017; 11/20/2017
• Supplement Dates FDA Received: 09/22/2017; 10/17/2017; 12/07/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/28/2017
• 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 Age: 59 YR