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

Model Number SC-1132

Device Problems Bent (1059); Break (1069); Fracture (1260); High impedance (1291); Kinked (1339); No Apparent Adverse Event (3189)

Patient Problems Pain (1994); No Information (3190)

Event Date 11/02/2015

Event Type  Injury  

Manufacturer Narrative

Event Description

A report was received that the patient will undergo a pocket revision procedure for an unknown reason.No device malfunction was suspected.

Manufacturer Narrative

Additional information was received that device malfunction was suspected with the ipg.It was noted that lead revision may be the course of action.

Event Description

A report was received that the patient will undergo a pocket revision procedure for an unknown reason.No device malfunction was suspected.

Manufacturer Narrative

Additional information was received that the patient was originally for pocket revision due to pain at the ipg site.It was on the impedance check that an excessively high impedances were found on the leads.The patient underwent a revision procedure wherein the ipg was moved to a more suitable depth and the leads were replaced, while two of the click anchors were removed.The physician did not suspect device malfunction but noted that the leads had kinked where the anchors were.The patient was reportedly doing well postoperatively.Additional suspect medical device components involved in the event: model #: sc-2218-50, serial #: (b)(4), description: linear st lead, 50cm.Model #: sc-4316, lot #: 14560668, description: next generation anchor kit-sterile.

Event Description

A report was received that the patient will undergo a pocket revision procedure for an unknown reason.No device malfunction was suspected.

Manufacturer Narrative

Sc-2218-50 sn (b)(4) device evaluation indicated that the complaint has been confirmed.Visual (microscope) and x-ray inspection of the lead revealed that multiple cables were completely broken at the bent/kinked location of the lead.The bent/kinked location is 1 cm from the set screw mark of the clik anchor.There are no exposed cables at the clik site fracture locations.The broken cables resulted in the reported complaint of high impedance.Sc-2218-50 sn (b)(4) device evaluation indicated that the complaint has been confirmed.Visual (microscope) and x-ray inspection of the lead revealed that multiple cables were completely broken at the bent/kinked location of the lead.The bent/kinked location is 1 cm from the set screw mark of the clik anchor.There are no exposed cables at the clik site fracture locations.The broken cables resulted in the reported complaint of high impedance.Sc-4316 ln 14560668 a review of the manufacturing documentation for the clik anchor revealed that no anomalies or deviations potentially related to the event occurred during manufacturing.

Event Description

A report was received that the patient will undergo a pocket revision procedure for an unknown reason.No 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: 5259229
• MDR Text Key: 32450165
• Report Number: 3006630150-2015-03134
• Device Sequence Number: 1
• Product Code: LGW
• 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: 11/06/2015

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: 10/31/2015
• Device Model Number: SC-1132
• Other Device ID Number: M365SC11320
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/03/2016
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/12/2015
• Initial Date FDA Received: 12/01/2015
• Supplement Dates Manufacturer Received: Not provided; Not provided; Not provided
• Supplement Dates FDA Received: 01/18/2016; 03/15/2016; 04/20/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/10/2013
• 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: 56 YR