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

Model Number SC-1160

Device Problems Fracture (1260); Overheating of Device (1437); Material Separation (1562)

Patient Problems Wound Dehiscence (1154); Burn(s) (1757)

Event Date 11/17/2017

Event Type  Injury  

Manufacturer Narrative

Additional suspect medical device components involved in the event: model #: sc-8216-70 serial #: (b)(4) description: artisan surgical lead 70cm model #: sc-5312 serial #: (b)(4) description: scs charger 2.0.

Event Description

A report was received that the patient had a blister as the charger became hot when charging the ipg.It was also reported that the ipg site became tender and the incision had opened up.The cause of the blister was unknown and the physician was uncertain if there was device malfunction.The patient was hospitalized and underwent an explant procedure.It was noted that the tails of the leads were completely fractured and each line to the contacts were exposed.The patient was doing well postoperatively.

Manufacturer Narrative

Sc-1160 (b)(4) device evaluation indicated that the ipg passed all tests performed.Sc-8216-70 (b)(4) device evaluation indicated that the proximal ends were not returned.Contacts were dislodged from the paddle.Review of the sterilization records did not find any anomalies or deviations that potentially relate to the reported event.Damage to the leads resulted of a typical explant procedure and it was not considered a failure.

Event Description

A report was received that the patient had a blister as the charger became hot when charging the ipg.It was also reported that the ipg site became tender and the incision had opened up.The cause of the blister was unknown and the physician was uncertain if there was device malfunction.The patient was hospitalized and underwent an explant procedure.It was noted that the tails of the leads were completely fractured and each line to the contacts were exposed.The patient was doing well postoperatively.

• Brand Name: SPECTRA WAVEWRITER
• 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: 7098361
• MDR Text Key: 94192314
• Report Number: 3006630150-2017-04993
• Device Sequence Number: 1
• Product Code: LGW
• UDI-Device Identifier: 08714729951254
• UDI-Public: 08714729951254
• 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
• Report Date: 01/16/2018

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?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 04/03/2019
• Device Model Number: SC-1160
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/30/2017
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/17/2017
• Initial Date FDA Received: 12/07/2017
• Supplement Dates Manufacturer Received: 01/03/2018
• Supplement Dates FDA Received: 01/16/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/10/2017
• 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): Hospitalization; Required Intervention
• Patient Age: 45 YR