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

Model Number SC-2218-50

Device Problems Bent (1059); Fracture (1260); High impedance (1291); Kinked (1339); Migration or Expulsion of Device (1395)

Patient Problem Inadequate Pain Relief (2388)

Event Date 08/23/2017

Event Type  malfunction  

Manufacturer Narrative

Additional suspect medical device component involved in the event: model #: sc-2218-50 serial #: (b)(4) description: linear st lead, 50cm it is indicated that the devices will not be returned for evaluation; therefore a failure analysis of the complaint devices could not be completed.A review of the device history records will be conducted.If there is any further relevant information from that review, a supplemental med watch will be filed.

Event Description

A report was received that the patient was experiencing inadequate stimulation due to high impedance, elevated contacts and lead migration on lead was noted.The patient underwent a revision procedure wherein the ipg and leads and click anchor where replaced.The patient was doing well postoperatively.

Manufacturer Narrative

Sc-2218-50 (sn (b)(4)) device evaluation indicated that the visual inspection revealed that lead was slashed at 12 cm from proximal end and cables are exposed.X-ray inspection found no cable breakage.Sc-2218-50 (sn (b)(4)) device evaluation indicated that the complaint has been confirmed.Visual inspection found lead body was bent/ kinked/damaged at the clik anchor site, 1 cm from the set screw mark.The fracture location is 22 cm from the distal end.X-ray inspection confirmed all cables were fractured.There are no exposed cables at the clik site fracture.The fractured cables resulted in the reported loss of stimulation.

Event Description

A report was received that the patient was experiencing inadequate stimulation due to high impedance, elevated contacts and lead migration on lead was noted.The patient underwent a revision procedure wherein the ipg and leads and click anchor where replaced.The patient was doing well postoperatively.

• 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: 6853692
• MDR Text Key: 85577187
• Report Number: 3006630150-2017-03477
• Device Sequence Number: 1
• Product Code: LGW
• UDI-Device Identifier: 08714729767725
• UDI-Public: 08714729767725
• 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: 08/23/2017

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: 11/01/2014
• Device Model Number: SC-2218-50
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/07/2017
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/22/2017
• Initial Date FDA Received: 09/08/2017
• Supplement Dates Manufacturer Received: 10/11/2017
• Supplement Dates FDA Received: 10/27/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/29/2012
• 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: 71 YR