MAUDE Adverse Event Report: BOSTON SCIENTIFIC NEUROMODULATION SPLITTER 2X8 KIT-STERILE; STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF

Model Number	SC-3400-30
Medical Device Problem Codes	High impedance (1291); Unexpected Therapeutic Results (1631)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	01/28/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Model number/catalog number: sc-1132; serial number: (b)(4); batch/lot number: 17505772; model/catalog description: precision spectra ipg kit.Model number/catalog number: sc-2316-70; serial number: (b)(4); batch/lot number: 17489738 | 17561359; model/catalog description: infinion 16 lead kit 70 cm 6511.Model number/catalog number: sc-3400-30; serial number: (b)(4); batch/lot number: 17613422; model/catalog description: splitter 2x8 kit-sterile.
Event or Problem Description
A report was received that the patient was experiencing inadequate stimulation.It was noted that splitters had high impedances.The patient underwent an explant procedure and was doing well postoperatively.
Additional Manufacturer Narrative
Sc-3400-30 (sn: (b)(4)) device evaluation indicated that the devices passed all tests performed and revealed no anomalies.Sc-2316-70 (sn: (b)(4)) device evaluoation indicated that the complaint of inadequate stimulation was confirmed.Visual inspection of the lead revealed that all of the cables were completely broken 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 are no exposed cables at the fracture location.The lead gets kinked after it exits the clik anchor resulting in the reported complaint.
Event or Problem Description
A report was received that the patient was experiencing inadequate stimulation.It was noted that splitters had high impedances.The patient underwent an explant procedure and was doing well postoperatively.
Event or Problem Description
A report was received that the patient was experiencing inadequate stimulation.It was noted that splitters had high impedances.The patient underwent an explant procedure and was doing well postoperatively.
Additional Manufacturer Narrative
Sc-3400-30, sn: (b)(4).Device evaluation indicated that the devices passed all tests performed and revealed no anomalies.

• Brand Name: SPLITTER 2X8 KIT-STERILE
• 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: 8345611
• Report Number: 3006630150-2019-00598
• Device Sequence Number: 19313686
• Product Code: LGW
• UDI-Device Identifier: 08714729797838
• UDI-Public: 08714729797838
• Combination Product (Y/N): N
• Initial Reporter State: SC
• Initial Reporter Country: US
• PMA/510(K) Number: P030017
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/30/2019

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?: No
• Operator of Device: Lay User/Patient
• Device Expiration Date: 01/05/2017
• Device Model Number: SC-3400-30
• Device Catalogue Number: SC-3400-30
• Device Lot Number: 17559899
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/27/2019
• Initial Date Received by Manufacturer: 01/28/2019
• Supplement Date Received by Manufacturer: 03/29/2019; 05/30/2019
• Initial Report FDA Received Date: 02/15/2019
• Supplement Report FDA Received Date: 04/15/2019; 05/30/2019
• 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: 63 YR