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

Model Number SC-2218-70

Device Problems Bent (1059); Break (1069); Fracture (1260); High impedance (1291); Kinked (1339); Component Missing (2306)

Patient Problem Inadequate Pain Relief (2388)

Event Date 06/28/2017

Event Type  malfunction  

Manufacturer Narrative

Additional suspect medical device components involved in the event: model#: sc-2218-70 serial #: (b)(4) description: linear st lead, 70cm model#: sc-3138-35 serial #: (b)(4) description: scs phiii ext 35cm model#: sc-4316 lot #: 20681114 description: generation anchor kit-sterile.

Event Description

A report was received that following a non-device related fall, the patient was not getting adequate stimulation in his neck.X-ray was taken and revealed that one cervical lead had high impedances.The patient underwent a lead replacement procedure.It was noted that device malfunction was suspected.The patient was doing well postoperatively.

Manufacturer Narrative

Additional suspect medical device component involved in the event: model #: sc-2218-70 serial #: (b)(4) description: linear st lead, 70cm.

Event Description

A report was received that following a non-device related fall, the patient was not getting adequate stimulation in his neck.X-ray was taken and revealed that one cervical lead had high impedances.The patient underwent a lead replacement procedure.It was noted that device malfunction was suspected.The patient was doing well postoperatively.

Manufacturer Narrative

Sc-2218-70 (sn (b)(4)): device evaluation indicated that the lead complaint had been confirmed.Visual (microscope) and x-ray inspection of the lead revealed that all cables were completely broken at the bent/kinked location of the lead.The bent/kinked location was 1 cm from the set screw mark of the clik anchor.There were no exposed cables at the clik site fracture locations.The broken cables resulted in the reported complaint of high impedance.Sc-2218-70 (sn (b)(4)): device evaluation indicated that the lead complaint of high impedance was confirmed.X-ray inspection of the lead revealed contact # 4 cables completely broken in the proximal array.The broken cables resulted in the reported complaint of high impedance.Review of the dhr did not indicate any anomaly.Sc-3138-35 (sn (b)(4)): device evaluation indicated that complaint was not verified.The lead passed all tests including visual/xray/borescope inspection, impedance, diameter, and electrode pitch tests.Device exhibits normal device characteristics.Sc-4316 (ln 20681114): device evaluation indicated that the visual inspection found that one of the clik anchors has torn eyelets, and a small piece of silicone was not returned.The other clik anchor was exhibiting normal characteristics.

Event Description

A report was received that following a non-device related fall, the patient was not getting adequate stimulation in his neck.X-ray was taken and revealed that one cervical lead had high impedances.The patient underwent a lead replacement procedure.It was noted that device malfunction was suspected.The patient was doing well postoperatively.

Manufacturer Narrative

Additional information was received that according to the physician, all products were removed from the patient.

Event Description

A report was received that following a non-device related fall, the patient was not getting adequate stimulation in his neck.X-ray was taken and revealed that one cervical lead had high impedances.The patient underwent a lead replacement procedure.It was noted that device malfunction was suspected.The patient was doing well postoperatively.

• 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: 6866962
• MDR Text Key: 86258081
• Report Number: 3006630150-2017-03618
• Device Sequence Number: 1
• Product Code: LGW
• UDI-Device Identifier: 08714729767749
• UDI-Public: 08714729767749
• 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,Followup
• Report Date: 11/23/2017

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: 11/01/2013
• Device Model Number: SC-2218-70
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/20/2017
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/15/2017
• Initial Date FDA Received: 09/14/2017
• Supplement Dates Manufacturer Received: 08/15/2017; 10/20/2017; 11/10/2017
• Supplement Dates FDA Received: 10/10/2017; 11/09/2017; 11/23/2017
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 12/07/2011
• 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: 54 YR