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

Model Number SC-1132

Device Problem Telemetry Discrepancy (1629)

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

Event Date 06/19/2017

Event Type  malfunction  

Event Description

A report was received that the patient was having difficulty linking the remote control to ipg.The patient will undergo an ipg replacement procedure.

Manufacturer Narrative

Sc-1132 (b)(4): the complaint was confirmed.The antenna coil became dislodged from the lcp frame, and one of the coil ends was fractured at the solder site.The two components have been assembled using rtv adhesive, which is applied at the board vendor.Excessive stress and/or fatigue on the wire where it is soldered to the pin are the result of movement between the coil and the frame.

Event Description

A report was received that the patient was having difficulty linking the remote control to ipg.The patient will undergo an ipg replacement procedure.

Manufacturer Narrative

Additional information was received that the patient underwent an ipg replacement procedure.Device malfunction was suspected by the physician.The patient was doing well postoperatively.

Event Description

A report was received that the patient was having difficulty linking the remote control to ipg.The patient will undergo an ipg replacement procedure.

• 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: 6723367
• MDR Text Key: 80381409
• Report Number: 3006630150-2017-02612
• Device Sequence Number: 1
• Product Code: LGW
• UDI-Device Identifier: 08714729821526
• UDI-Public: (01)08714729821526(17)190331(10)20464200
• 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: 06/27/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/18/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 03/31/2019
• Device Model Number: SC-1132
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/25/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/11/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/05/2017
• 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: 59 YR