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

Model Number SC-2218-70

Device Problems Bent (1059); Fracture (1260); High impedance (1291); Kinked (1339); Device Or Device Fragments Location Unknown (2590)

Patient Problem Inadequate Pain Relief (2388)

Event Date 09/24/2015

Event Type  malfunction  

Manufacturer Narrative

Concomitant medical products: model #: sc-2218-70, serial #: (b)(4), description: linear st lead, 70cm.Model #: sc-1110-02, serial #: (b)(4), description: precision implantable pulse generator (ipg).

Event Description

A report was received that the patient lost stimulation.Database analysis revealed 15 contacts with high impedances.The charge profile also showed that the charger to ipg coupling was not always ideal and the charger thermistor triggered often which could prolong charging times.The device appeared to be working as expected.Computerized tomography (ct) scan was taken but the result was normal.The patient underwent a revision procedure wherein the lead and the ipg were replaced.It was noted that the cause of the high impedances were unknown.The patient was reportedly doing well post operatively.

Manufacturer Narrative

(b)(4).

Event Description

A report was received that the patient lost stimulation.Database analysis revealed 15 contacts with high impedances.The charge profile also showed that the charger to ipg coupling was not always ideal and the charger thermistor triggered often which could prolong charging times.The device appeared to be working as expected.Computerized tomography (ct) scan was taken but the result was normal.The patient underwent a revision procedure wherein the lead and the ipg were replaced.It was noted that the cause of the high impedances were unknown.The patient was reportedly doing well post operatively.

Manufacturer Narrative

Device evaluation indicated that the source of the complaint was verified to be the associated leads whose cables were fractured at the clik anchor site.Sc-1110 (sn (b)(4)): device evaluation indicated that the device passed the functional test and revealed no anomalies.Sc-2218-70 (sn (b)(4) & (b)(4): device evaluation indicated that all cables were fractured at the bent/kinked sections of the lead body, at apparent a clik anchor site, 1 cm from the set screw mark.Sc-4316 (lot # 15225563): device evaluation indicated that one of the clik anchors is missing a silicone eyelet.

Event Description

A report was received that the patient lost stimulation.Database analysis revealed 15 contacts with high impedances.The charge profile also showed that the charger to ipg coupling was not always ideal and the charger thermistor triggered often which could prolong charging times.The device appeared to be working as expected.Computerized tomography (ct) scan was taken but the result was normal.The patient underwent a revision procedure wherein the lead and the ipg were replaced.It was noted that the cause of the high impedances were unknown.The patient was reportedly doing well post operatively.

Manufacturer Narrative

Additional information was received that the missing silicone eyelet was not left inside the patient¿s body.

Event Description

A report was received that the patient lost stimulation.Database analysis revealed 15 contacts with high impedances.The charge profile also showed that the charger to ipg coupling was not always ideal and the charger thermistor triggered often which could prolong charging times.The device appeared to be working as expected.Computerized tomography (ct) scan was taken but the result was normal.The patient underwent a revision procedure wherein the lead and the ipg were replaced.It was noted that the cause of the high impedances were unknown.The patient was reportedly doing well post operatively.

• 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: 5308191
• MDR Text Key: 33826753
• Report Number: 3006630150-2015-03395
• 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,Followup
• Report Date: 09/24/2015

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: 05/31/2017
• Device Model Number: SC-2218-70
• Other Device ID Number: M365SC2218700
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/17/2015
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/01/2015
• Initial Date FDA Received: 12/17/2015
• Supplement Dates Manufacturer Received: Not provided; Not provided; Not provided
• Supplement Dates FDA Received: 12/23/2015; 01/30/2016; 02/29/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/14/2012
• 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: 73 YR