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

Model Number	SC-2158-50
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	01/16/2020
Type of Reportable Event	Malfunction
Event or Problem Description
A report was received that during the patients ipg revision procedure (mfr 3006630150-2020-00322) the lead was fractured which was a result of the physician pulling hard to remove the leads.
Additional Manufacturer Narrative
Sc-2158-50 (sn: (b)(6).The returned device was analyzed, and the reported event was confirmed.Contact # 8 in the proximal array was overly flattened when the setscrew was locked down.The deformed contact #8 resulted in the inability to remove the proximal array from the ipg header.Therefore, the probable cause selected is unintended use error caused or contributed to event.
Event or Problem Description
A report was received that during the patients ipg revision procedure (mfr 3006630150-2020-00322) the lead was fractured which was a result of the physician pulling hard to remove the leads.Additional information was received that only returned product was the proximal connector end inside the associated ipg.

• 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: 9675933
• Report Number: 3006630150-2020-00411
• Device Sequence Number: 2668321
• Product Code: LGW
• UDI-Device Identifier: 08714729767695
• UDI-Public: 08714729767695
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: P030017
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2012
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/20/2020

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
• Operator of Device: Lay User/Patient
• Device Expiration Date: 06/12/2017
• Device Model Number: SC-2158-50
• Device Catalogue Number: SC-2158-50
• Device Lot Number: 15296969
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/29/2020
• Initial Date Received by Manufacturer: 01/16/2020
• Supplement Date Received by Manufacturer: 07/24/2020
• Initial Report FDA Received Date: 02/06/2020
• Supplement Report FDA Received Date: 08/21/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 71 YR