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

Model Number SC-8336-50

Device Problem Material Separation (1562)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 11/02/2016

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

A report was received that during an implant procedure the patient¿s lead contact popped out.

Manufacturer Narrative

Required intervention to prevent permanent damage should not have been checked.Additional information was received that the contacts were removed from the patient's body.Lead sc-8336-50: the complaint was confirmed.Visual inspection revealed that electrodes # 7 and 8 are missing from paddle end of lead.The cables are exposed.Review of the dhr found no anomalies when the lead was manufactured.

Event Description

A report was received that during an implant procedure, the patient¿s lead contact pop out.

• 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: 6136836
• MDR Text Key: 61186416
• Report Number: 3006630150-2016-03480
• 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: 11/02/2016

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: 10/05/2018
• Device Model Number: SC-8336-50
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/07/2016
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/02/2016
• Initial Date FDA Received: 11/30/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 12/14/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/10/2016
• 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: 72 YR