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

Model Number SC-8336-50

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

Patient Problems Fall (1848); Inadequate Pain Relief (2388); Device Embedded In Tissue or Plaque (3165)

Event Date 12/22/2015

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

A report was received that the patient was not receiving stimulation.X-ray confirmed lead migration.The patient underwent a revision procedure.During the procedure, it was discovered that the lead was fractured and four contacts came undone.The physician decided to explant the system.No device malfunction was suspected as the patient fell and the lead migrated.The four contacts were left inside the patient's body per physician's decision.

Manufacturer Narrative

Sc-8336-50 (sn (b)(4)): device evaluation indicated that the complaint of loss of stimulation due to lead migration was confirmed.Visual inspection revealed distal electrode #'s 8, 14, 15, 16, 24, and 30 were completely dislodged from the paddle silicone and not returned.Electrode #29 was partially dislodged from the silicone but still electrically connected.Proximal ends were cut and not returned.Paddle silicone was torn.When the paddle lead migrated from the epidural space it caused the electrodes to become completely dislodged from the paddle because of the friction and grinding forces the spine exerted on it.It also tore/ripped the silicone of the paddle.Exposed cables.Sc-4316 (lot #: 18262617): device evaluation indicated that the visual inspection of the clik anchor revealed 2 eyelets were fractured and exhibited missing silicon.Root cause of the damage was not determined.Additional information was received that no anchors were left inside the patient¿s body.

Event Description

A report was received that the patient was not receiving stimulation.X-ray confirmed lead migration.The patient underwent a revision procedure.During the procedure, it was discovered that the lead was fractured and four contacts came undone.The physician decided to explant the system.No device malfunction was suspected as the patient fell and the lead migrated.The four contacts were left inside the patient's body per physician's decision.

• 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: 5424211
• MDR Text Key: 37836203
• Report Number: 3006630150-2016-00230
• 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
• Report Date: 12/22/2015

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: 06/30/2017
• Device Model Number: SC-8336-50
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/03/2016
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/18/2016
• Initial Date FDA Received: 02/09/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 03/31/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/25/2015
• 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: 61 YR