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

Model Number SC-8216-70

Device Problems Break (1069); Fracture (1260); Material Frayed (1262); Telemetry Discrepancy (1629)

Patient Problem Inadequate Pain Relief (2388)

Event Date 08/31/2015

Event Type  Injury  

Manufacturer Narrative

Additional suspect medical device component involved in the event: model #: sc-1132, serial #: (b)(4), description: precision spectra implantable pulse generator.

Event Description

A report was received that during a revision procedure when the physician opened the incision where the paddle was, the paddle lead was frayed and part of the lead was broken.The lead was replaced.At the end of the procedure, the ipg was replaced as well because there was no response when the ipg was linked with the remote control.It was also reported that the patient had a history of car accident after the permanent implant and patient lost stimulation.Device malfunction was suspected.The patient was doing well postoperatively.

Manufacturer Narrative

Sc-1132 sn: (b)(4) device evaluation indicated that the complaint was confirmed.The device could not be charged nor linked even after three charging attempts.The battery measured only 1.77 volts.It exhibited excessive sleep current leakage (38 ma).A hot spot was observed on u2-asic (34.7°c), and vh and ground were shorted (55 ohms).These symptoms were the typical characteristics of high-voltage transient damage.The use of electrocautery during the explant procedure was the root cause of the complaint.Sc-8216-70 sn: (b)(4) the cable of e8 was fractured right at the paddle end.

Event Description

A report was received that during a revision procedure when the physician opened the incision where the paddle was, the paddle lead was frayed and part of the lead was broken.The lead was replaced.At the end of the procedure, the ipg was replaced as well because there was no response when the ipg was linked with the remote control.It was also reported that the patient had a history of car accident after the permanent implant and patient lost stimulation.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: 5096844
• MDR Text Key: 26524458
• Report Number: 3006630150-2015-02440
• 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
• Report Date: 08/31/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/23/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 12/31/2015
• Device Model Number: SC-8216-70
• Other Device ID Number: M365SC8216700
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/04/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/06/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/14/2014
• 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: 62 YR