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

Model Number SC-2352-50

Device Problems Fracture (1260); Cut In Material (2454)

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

Event Date 08/29/2017

Event Type  Injury  

Manufacturer Narrative

Additional suspect medical device component involved in the event: model #: sc-2352-50, serial #: (b)(4), description: linear 3-4 lead, 50cm.

Event Description

A report was received that during a revision procedure (mfr report#:3006630150-2017-03524), the physician noticed that a lead was not placed in the battery due to it being cut in half.The physician confirmed that there was no way possible he could have cut the lead as the wires were tucked under the battery.

Manufacturer Narrative

Additional information was received that no further course of action will be taken at this time.

Event Description

A report was received that during a revision procedure (mfr report#:3006630150-2017-03524), the physician noticed that a lead was not placed in the battery due to it being cut in half.The physician confirmed that there was no way possible he could have cut the lead as the wires were tucked under the battery.

• Brand Name: PRECISION
• 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: 6877866
• MDR Text Key: 86690492
• Report Number: 3006630150-2017-03516
• Device Sequence Number: 1
• Product Code: LGW
• UDI-Device Identifier: 08714729789550
• UDI-Public: 08714729789550
• 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: 08/29/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/19/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 04/01/2013
• Device Model Number: SC-2352-50
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/03/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/20/2011
• 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: 73 YR