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

Model Number SC-1110-02

Device Problems Failure to Charge (1085); Component Missing (2306); Cut In Material (2454)

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

Event Date 03/02/2017

Event Type  Injury  

Event Description

A report was received that the patient's ipg would not take a charge.The patient will undergo a revision procedure.

Manufacturer Narrative

Additional information was received that the patient underwent a revision procedure wherein the ipg was replaced.No device malfunction was suspected.The patient was reportedly doing well postoperatively.

Event Description

A report was received that the patient's ipg would not take a charge.The patient will undergo a revision procedure.

Manufacturer Narrative

Sc-1110-02 ((b)(4)) device evaluation indicated that the ipg passed all tests performed.Sc-2218-50 ((b)(4)) device evaluation indicated that the source of the complaint regarding pocket pain was not determined.The distal tip was cut off and four electrodes were missing.Damage to the device was similar to the typical explant damage and was not considered.

Event Description

A report was received that the patient's ipg would not take a charge.The patient will undergo a revision procedure.

• 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: 6426742
• MDR Text Key: 70622458
• Report Number: 3006630150-2017-00805
• Device Sequence Number: 1
• Product Code: LGW
• UDI-Device Identifier: 08714729767688
• UDI-Public: (01)08714729767688(17)131101(10)14794555
• 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: 03/02/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/22/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 11/01/2013
• Device Model Number: SC-1110-02
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/15/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/05/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/23/2011
• 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 Outcome(s): Required Intervention
• Patient Age: 60 YR