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

Model Number SC-8336-50

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

Patient Problems Pain (1994); Inadequate Pain Relief (2388); No Known Impact Or Consequence To Patient (2692); Device Embedded In Tissue or Plaque (3165)

Event Date 04/27/2018

Event Type  malfunction  

Event Description

A report was received that the patients lead had migrated.It was also reported that the lead was clearly damaged.The patient underwent a revision procedure wherein the lead was replaced.

Manufacturer Narrative

Additional information was received that there was a contact left inside the patients body per physicians preference.

Event Description

A report was received that the patients lead had migrated.It was also reported that the lead was clearly damaged.The patient underwent a revision procedure wherein the lead was replaced.

Manufacturer Narrative

Additional information was received that the patient was experiencing pain at the lead site and loss of paresthesia due to the lead being ripped apart.The patient was doing well postoperatively.Sc-8336-50 (b)(4) device evaluation indicated that the lead being ripped apart had been confirmed.The returned paddle lead exhibited extensive damage.Visual inspection revealed that paddle was missing electrodes # 7,8, and 24.The bottom portion of the paddle close to the pigtails were torn and was not returned.It appeared that excessive tensile force were exerted onto the lead and resulted in electrode dislodgement and the paddle damage.The cause of the lead migration could not be determined.Additionally, all four pigtails were clean cut and the insulation of each pigtail were pulled exposing all 32 individual cables.The proximal portions of the pigtails were not returned.This type of damage is a result of a typical explant procedure and it is not considered a failure.

Event Description

A report was received that the patients lead had migrated.It was also reported that the lead was clearly damaged.The patient underwent a revision procedure wherein the lead was replaced.

• Brand Name: PRECISION SPECTRA
• Type of Device: SPINA 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: 7525525
• MDR Text Key: 108632600
• Report Number: 3006630150-2018-01739
• Device Sequence Number: 1
• Product Code: LGW
• UDI-Device Identifier: 08714729832669
• UDI-Public: 08714729832669
• 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,Followup
• Report Date: 06/28/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 10/16/2019
• Device Model Number: SC-8336-50
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/17/2018
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/27/2018
• Initial Date FDA Received: 05/18/2018
• Supplement Dates Manufacturer Received: 05/25/2018; 06/21/2018
• Supplement Dates FDA Received: 06/18/2018; 06/28/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/23/2017
• 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 Age: 55 YR