MAUDE Adverse Event Report: BOSTON SCIENTIFIC NEUROMODULATION LINEAR; STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF

Model Number	SC-2158-70
Medical Device Problem Code	High impedance (1291)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	08/20/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Model number / catalog number: sc-2158-50, serial number: (b)(4), batch / lot number: 20455086, model / catalog description: linear lead kit 50 cm.
Event or Problem Description
A report was received that the patients leads had high impedances.The patient underwent a lead replacement procedure and was doing well postoperatively.
Additional Manufacturer Narrative
Sc-2158-70 (sn (b)(4)).Device evaluation indicated that the complaint regarding the impedance anomaly has been confirmed.The proximal tip was sharply bent and e2 cable was fractured.It appears that excessive mechanical force was exerted onto the proximal end resulting in the fracture.Additionally, the 70 centimeter lead was cleanly cut and the distal portion about 22 centimeters was not returned.The cut damage to the lead was a result of a typical explant procedure and it was not considered a failure.Sc-2158-50 (sn (b)(4)).Device evaluation indicated that visual inspection of the lead revealed that three cables were fractured at the bent/kinked location of the lead.The bent/kinked location is 1 cm from the set screw mark of the clik anchor.There were no exposed cables at the fracture location.The lead got kinked after it exited the clik anchor resulting in the reported complaint.
Event or Problem Description
A report was received that the patients leads had high impedances.The patient underwent a lead replacement procedure and was doing well postoperatively.

• Brand Name: LINEAR
• Common Device Name: STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF
• Manufacturer (Section D): BOSTON SCIENTIFIC NEUROMODULATION; 25155 rye canyon loop; valencia CA 91355
• MDR Report Key: 8970299
• Report Number: 3006630150-2019-04880
• Device Sequence Number: 10810123
• Product Code: LGW
• UDI-Device Identifier: 08714729767718
• UDI-Public: 08714729767718
• Combination Product (Y/N): N
• Initial Reporter State: UT
• Initial Reporter Country: US
• PMA/510(K) Number: P030017
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/24/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Expiration Date: 12/31/2016
• Device Model Number: SC-2158-70
• Device Catalogue Number: SC-2158-70
• Device Lot Number: 17513760
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/04/2019
• Initial Date Received by Manufacturer: 08/20/2019
• Supplement Date Received by Manufacturer: 10/04/2019
• Initial Report FDA Received Date: 09/06/2019
• Supplement Report FDA Received Date: 10/24/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 62 YR