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

Model Number SC-8120-70

Device Problems Break (1069); High impedance (1291)

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

Event Date 10/19/2017

Event Type  malfunction  

Event Description

A report was received that during the patient's recent surgery (mfr report #: 3006630150-2017-04749), the lead was discovered to be damaged at the proximal end.It was also noted that there were high impedances on two contacts.The physician cut the proximal end of the lead and left the remaining lead in the body.The patient will undergo a revision procedure wherein the lead will be replaced.

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 the patients recent surgery (mfr report #: 3006630150-2017-04749), the lead was discovered to be damaged at the proximal end.It was also noted that there were high impedances on two contacts.The physician cut the proximal end of the lead and left the remaining lead in the body.The patient will undergo a revision procedure wherein the lead will be replaced.

Manufacturer Narrative

Additional information was received that the patient underwent a lead replacement procedure.No device malfunction was suspected.The patient was doing well postoperatively.The explanted device was not returned to bsn.A review of the manufacturing documentation for the lead revealed that no anomalies or deviations potentially related to the event occurred during manufacturing.

Event Description

A report was received that during the patients recent surgery (mfr report #: 3006630150-2017-04749), the lead was discovered to be damaged at the proximal end.It was also noted that there were high impedances on two contacts.The physician cut the proximal end of the lead and left the remaining lead in the body.The patient will undergo a revision procedure wherein the lead will be replaced.

• 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: 7155230
• MDR Text Key: 96066266
• Report Number: 3006630150-2017-05516
• 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,Followup
• Report Date: 05/11/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/29/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 03/31/2009
• Device Model Number: SC-8120-70
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/20/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/31/2007
• 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: 56 YR