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

Model Number SC-2316-50

Device Problems Bent (1059); Break (1069); Fracture (1260); High impedance (1291); Kinked (1339); Failure to Align (2522)

Patient Problems Undesired Nerve Stimulation (1980); Inadequate Pain Relief (2388)

Event Date 02/25/2015

Event Type  Injury  

Manufacturer Narrative

Additional suspect medical device components involved in the event: model #: sc-2316-50 serial #: (b)(4) description: infinion1x16 perc lead kit-50 cm model #: sc-3400-30 serial #: (b)(4) description: infinion splitter 2x8 kit (30 cm) model #: sc-4316 lot #: 16552647 description: next generation anchor kit-sterile.

Event Description

A report was received that the patient was experiencing uncomfortable stimulation then eventually lost coverage.The patient's lead revealed high impedances on almost all contacts.The physician asked if it was due to the splitters or the clik anchors or both.During the procedure, the physician first tried to disconnect and reconnect splitters, but the result remained the same.The physicians chose to explant everything and replaced both leads and were sutured directly with no clik anchors.The patient was reportedly doing well postoperatively.

Manufacturer Narrative

Additional information was received that another lead splitter was also explanted during the revision procedure.Additional suspect medical device component involved in the event: model #: sc-3400-30, serial/lot #: (b)(4), description: infinion splitter 2x8 kit (30 cm).Sc-2316-50, (sn (b)(4)): device evaluation indicated that the complaint of high lead impedance was confirmed.Visual inspection found proximal contact #16 of the lead was crushed by the splitter setscrew.Additionally, visual inspection found that the lead proximal end was fractured between contacts # 6 and 7.X-ray inspection of the lead revealed that seven cables were completely broken at the bent/kinked location of the lead.No cables were exposed.Because of this all contacts were misaligned with the spring contact.This was the root cause of the high impedance reading.Sc-2316-50 (sn (b)(4)): device evaluation indicated that the complaint had been confirmed.Visual (microscope) and x-ray inspection of the lead revealed that all of the cables were completely broken at the bent/kinked location of the lead, approximately 24 cm from the distal e nd.The bent/kinked location was 1 cm from the set screw mark of the clik anchor.The cables were exposed at the fracture site.The broken cables resulted in the reported complaint of high impedance.Sc-3400-30 (sn (b)(4)): device evaluation indicated that the devices passed all tests performed.The complaint was not verified.A test infinion lead was inserted into the splitters connector without any anomalies.Devices exhibited normal device characteristics.Sc-4316 (lot# 16552647): device evaluation indicated that visual inspection found that one of the clik anchors had torn eyelets, and a small piece of silicone was not returned.The other clik anchor exhibited normal characteristics.

Event Description

A report was received that the patient was experiencing uncomfortable stimulation then eventually lost coverage.The patient's lead revealed high impedances on almost all contacts.The physician asked if it was due to the splitters or the clik anchors or both.During the procedure, the physician first tried to disconnect and reconnect splitters, but the result remained the same.The physicians chose to explant everything and replaced both leads and were sutured directly with no clik anchors.The patient was reportedly doing well postoperatively.

Manufacturer Narrative

Additional information was received that the missing silicone was removed from the patient¿s body.The physician confirmed that all products were removed.

Event Description

A report was received that the patient was experiencing uncomfortable stimulation then eventually lost coverage.The patient's lead revealed high impedances on almost all contacts.The physician asked if it was due to the splitters or the clik anchors or both.During the procedure, the physician first tried to disconnect and reconnect splitters, but the result remained the same.The physicians chose to explant everything and replaced both leads and were sutured directly with no clik anchors.The patient was reportedly 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: 5148335
• MDR Text Key: 28215716
• Report Number: 3006630150-2015-02631
• 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: Followup,Followup
• Report Date: 02/25/2015

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-2316-50
• Other Device ID Number: M365SC2316500
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/01/2015
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/14/2015
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 11/05/2015; 11/30/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/15/2013
• 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: 58 YR