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

Model Number SC-8336-70

Device Problems Fracture (1260); Migration or Expulsion of Device (1395); Material Separation (1562)

Patient Problems Fall (1848); Inadequate Pain Relief (2388)

Event Date 01/09/2018

Event Type  Injury  

Event Description

A report was received that the patient was experiencing loss of stimulation after the patient had a fall.It was noted that the leads had migrated, frayed apart below the header, fractured and several contacts were dislodged.It was also reported that the lead fracture was done prior to the revision surgery, physician felt he retrieved all of the missing contacts.The patient underwent a lead replacement procedure.No device malfunction was suspected.The patient was doing well postoperatively.

Manufacturer Narrative

Sc-8336-70 (b)(4) device evaluation indicated that the complaint of lead damage has been confirmed.Visual inspection revealed that the body of the paddle end has been severely damaged.The paddle was split in half and it appears that excessive tensile force was exerted onto the lead bodies pulling the cables that are connected to the electrodes.Seven electrodes of the paddle end and two of the proximal end of the paddle lead were dislodged and not returned.There are exposed cables at the fracture location.Additionally, the lead bodies were cleanly cut.The clean cut damage to the device is consistent with damages done during the explant procedure and are not considered a failure.

Event Description

A report was received that the patient was experiencing loss of stimulation after the patient had a fall.It was noted that the leads had migrated, frayed apart below the header, fractured and several contacts were dislodged.It was also reported that the lead fracture was done prior to the revision surgery, physician felt he retrieved all of the missing contacts.The patient underwent a lead replacement procedure.No 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: 7265582
• MDR Text Key: 99873419
• Report Number: 3006630150-2018-00443
• Device Sequence Number: 1
• Product Code: LGW
• UDI-Device Identifier: 08714729832676
• UDI-Public: 08714729832676
• 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: 02/19/2018

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?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 07/17/2019
• Device Model Number: SC-8336-70
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/01/2018
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/09/2018
• Initial Date FDA Received: 02/12/2018
• Supplement Dates Manufacturer Received: 02/15/2018
• Supplement Dates FDA Received: 02/19/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/19/2017
• 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): Required Intervention
• Patient Age: 53 YR